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Data / Medical devices / United States / UPS Supply Chain Solutions, Inc.

UPS Supply Chain Solutions, Inc.: FDA-registered device maker in Mira Loma, CA, United States, 42 510(k) clearances

UPS Supply Chain Solutions, Inc. is registered with the FDA (registration 3009637528) in Mira Loma, CA, United States. It lists 15 device types. The FDA files 42 510(k) clearances under its listings, the newest dated February 11, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009637528
Address
11811 Landon Drive Suite 100, Mira Loma, CA, United States, 91752
Owner or operator
UPS Supply Chain Solutions, Inc. (10038314)
Roles
Repackager or relabeler
First device listed
January 13, 2020
Registered through
2026
Brand names listed
BACT/ALERT® AST, BACT/ALERT® BPA, BACT/ALERT® BPN, BACT/ALERT® FA PLUS, BACT/ALERT® FN PLUS, BACT/ALERT® I FA PLUS, BACT/ALERT® NST, BACT/ALERT® PF PLUS 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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 11, 2019K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusMDBSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
December 8, 2017K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
July 22, 2017K162950VITEK MSPEXSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
June 21, 2017K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
April 27, 2017K162385RAPIDEC CARBA NPPTJSubstantially EquivalentBiomerieux S.A.accessdata.fda.gov
March 13, 2017K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
February 13, 2017K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
February 1, 2017K163083VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 24, 2017K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)LONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
June 20, 2014K141149VITEK 2 AST GP CEFTAROLINELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 25, 2013K121455BACT/ALERT FN PLUS CULTURE BOTTLEMDBSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 25, 2013K121446BACT/ALERT PF PLUS CULTURE BOTTLEMDBSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 22, 2013K121461BACT/ALERT FA PLUS CULTURE BOTTLEMDBSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 15, 2012K122547GRAM POSTITVE CLINDAMYCINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
August 7, 2012K113783VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
June 29, 2012K113200VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAMLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
November 30, 2011K110106VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 14, 2011K103752VITEK 2 SYSTEMS (PC) 5.02 SOFTWARELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 21, 2010K093076VITEK 2 GRAM POSITIVE DOXCYCLINELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
August 14, 2009K091899VITEK 2 GRAM NEGATIVE MEROPENEMLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
June 18, 2009K091126VITEK 2 GRAM POSITIVE DAPTOMYCINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
February 18, 2009K083383VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
April 30, 2008K080201VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
December 10, 2007K073083VITEK 2 GRAM NEGATIVE PIPERACILLINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
November 16, 2007K072695VITEK 2 GRAM POSITIVE TIGECYCLINELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 15, 2007K072668VITEK 2 GRAM POSITIVE VANCOMYCINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
September 12, 2007K072038VITEK 2 GRAM NEGATIVE LEVOFLOXACINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 19, 2007K063597VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
January 11, 2007K063623VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
December 14, 2005K053097VITEK 2 GRAM POSITIVE CEFOXITIN SCREENLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
December 1, 2005K053186VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
August 16, 2005K051849VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
May 23, 2005K050976VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
September 14, 2004K041982VITEK 2 GRAM NEGATIVE ERTAPENEMLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
June 8, 2004K040845VITEK 2 ESBL TESTLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 31, 2003K032766VITEK 2 GRAM POSITIVE LINEZOLIDLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
October 31, 2003K032738VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
September 10, 2003K032399VITEK 2 GRAM POSITIVE MOXIFLOXACINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
August 13, 2003K031865VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
July 10, 2003K031410VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAELONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
March 29, 2002K020871VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACINLONSubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
April 29, 1988K880961ALCON SURGICAL PROCEDURE PACKSLROSubstantially EquivalentAlcon Laboratoriesaccessdata.fda.gov

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Updated February 11, 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.