Data / Medical devices / United States / UPS Supply Chain Solutions, Inc.
UPS Supply Chain Solutions, Inc.: FDA-registered device maker in Pedricktown, NJ, United States, 79 510(k) clearances and 1 PMA approval
UPS Supply Chain Solutions, Inc. is registered with the FDA (registration 3013718871) in Pedricktown, NJ, United States. It lists 17 device types. The FDA files 79 510(k) clearances and 1 PMA approval under its listings, the newest dated May 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013718871
- Address
- 7 Gateway Blvd, Pedricktown, NJ, United States, 08067
- Owner or operator
- UPS SUPPLY CHAIN SOLUTIONS, INC. (9073670)
- Roles
- Repackager or relabeler
- First device listed
- May 23, 2018
- Registered through
- 2026
- Brand names listed
- AST TEST KIT CARDS, BACT/ALERT BPA CULTURE BOTTLE, BACT/ALERT BPA EU 100 BTLS, BACT/ALERT BPN, BACT/ALERT BPN CULTURE BOTTLE, BACT/ALERT BPN EU 100 BTLS, BACT/ALERT FA PLUS (PLASTIC), BACT/ALERT FN PLUS (PLASTIC) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2019 | K190405 | BACT/ALERT MP Reagent System | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 7, 2019 | K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 26, 2019 | K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 20, 2019 | K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 19, 2017 | K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 22, 2017 | K162950 | VITEK MS | PEX | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 21, 2017 | K162737 | VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 27, 2017 | K162385 | RAPIDEC CARBA NP | PTJ | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| March 13, 2017 | K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 16, 2017 | K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 13, 2017 | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 1, 2017 | K163083 | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 24, 2017 | K163006 | VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 12, 2017 | K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 20, 2016 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 15, 2016 | K152075 | VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 25, 2016 | K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2016 | K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 19, 2014 | K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 5, 2014 | K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 20, 2014 | K141149 | VITEK 2 AST GP CEFTAROLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 10, 2013 | K131779 | VITEK 2 AST-ST TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 13, 2013 | K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 22, 2013 | K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121546 | VITEK 2 GRAM NEGATIVE DOXYCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 19, 2012 | K121100 | VITEK 2 AST STREPTOCOCUS VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2012 | K122547 | GRAM POSTITVE CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122359 | VITEK 2 STRPTOCOCCUS CEFTRIAXONE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 16, 2012 | K121863 | VITEK 2 AST-ST CEFOTAXIME | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 7, 2012 | K113783 | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 29, 2012 | K113200 | VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2012 | K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 17, 2012 | K111976 | VITEK 2 STREPTOCOCCUS ERYTHROMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113305 | VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 30, 2011 | K110106 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 26, 2011 | K112000 | VITEK 2 STREPTOCOCCUS PENICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 18, 2011 | K111909 | VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 14, 2011 | K103752 | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 3, 2011 | K112228 | VITEK 2 STREPTOCOCCUS LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 27, 2011 | K112129 | VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 15, 2011 | K112075 | VITEK 2 STRPTOCOCCUS AMPICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 12, 2011 | K111599 | VITEK 2 AST-ST LINEZOLID | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 21, 2010 | K093076 | VITEK 2 GRAM POSITIVE DOXCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 28, 2010 | K101566 | VITEK 2 YEAST CASPOFUNGIN | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 21, 2010 | K092454 | VITEK 2 YEAST VORICONAZOLE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 14, 2009 | K091899 | VITEK 2 GRAM NEGATIVE MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 18, 2009 | K091126 | VITEK 2 GRAM POSITIVE DAPTOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 16, 2009 | K082346 | VITEK 2 GRAM NEGATIVE DORIPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2009 | K083383 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 30, 2008 | K080201 | VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 23, 2008 | K073406 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 10, 2007 | K073083 | VITEK 2 GRAM NEGATIVE PIPERACILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 16, 2007 | K072695 | VITEK 2 GRAM POSITIVE TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2007 | K072668 | VITEK 2 GRAM POSITIVE VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 12, 2007 | K072038 | VITEK 2 GRAM NEGATIVE LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 19, 2007 | K063597 | VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 11, 2007 | K063623 | VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 19, 2006 | K061945 | VITEK 2 AST-YS FLUCONAZOLE | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 14, 2005 | K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 1, 2005 | K053186 | VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 29, 2005 | K052311 | VITEK 2 GRAM NEGATIVE TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 16, 2005 | K051849 | VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 23, 2005 | K050976 | VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 17, 2005 | K050002 | VITEK 2 COMPACT | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 14, 2004 | K041982 | VITEK 2 GRAM NEGATIVE ERTAPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 8, 2004 | K040845 | VITEK 2 ESBL TEST | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 12, 2003 | K032861 | VITEK 2 GRAM NEGATIVE MOXIFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 31, 2003 | K032766 | VITEK 2 GRAM POSITIVE LINEZOLID | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 31, 2003 | K032738 | VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 10, 2003 | K032399 | VITEK 2 GRAM POSITIVE MOXIFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 13, 2003 | K031865 | VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 10, 2003 | K031410 | VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 26, 2002 | K021123 | BACT/ALERT SN CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 18, 2002 | K020931 | BACT/ALERT SA CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 29, 2002 | K020871 | VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 2, 1978 | N50510 | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | LTW | 130 | October 17, 2001 | accessdata.fda.gov |
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Updated May 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.