Data / Medical devices / United States / Becton Dickinson Caribe Ltd.
Becton Dickinson Caribe Ltd.: FDA-registered device maker in Cayey, PR, United States, 54 510(k) clearances
Becton Dickinson Caribe Ltd. is registered with the FDA (registration 2647876) in Cayey, PR, United States. It lists 10 device types. The FDA files 54 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2647876
- Address
- VICKS DR., LOT No. 6, Cayey, PR, United States, 00737
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 13, 1996
- Registered through
- 2027
- Brand names listed
- BD Affirm VPIII Ambient Temperature Transport System, BD Affirm VPIII Microbial Identification Test, BD Affirm VPIII Sample Collection Sets, BD Affirm VPIII Sample Collection Swabs, BD AffirmVPIII Microbial Identification Test, BD BACTEC Lytic/10 Anaerobic/F Culture Vials, BD BACTEC Myco/F Lytic Culture Vials, BD BACTEC Peds Plus/F Culture Vials and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Gas Generating | KZJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Manufacturer | accessdata.fda.gov |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | 1 | Manufacturer | accessdata.fda.gov |
| Dna Probe, Gardnerella Vaginalis | MJM | 1 | Manufacturer | accessdata.fda.gov |
| Dna Probe, Trichomonas Vaginalis | MJK | 1 | Manufacturer | accessdata.fda.gov |
| Dna Probe, Yeast | MLA | 1 | Manufacturer | accessdata.fda.gov |
| Susceptibility Test Discs, Antimicrobial | JTN | 2 | Manufacturer | accessdata.fda.gov |
| Susceptibility Test Powders, Antimicrobial | JTT | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Culturing | MDB | 1 | Manufacturer | accessdata.fda.gov |
| System, Detection, Bacterial, For Platelet Transfusion Products | MZC | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| March 24, 2023 | K222591 | BD BACTEC Plus Aerobic/F Culture Vials | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 24, 2023 | K222559 | BD BACTEC Myco/F Lytic Culture Vials | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 21, 2022 | K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | JTN | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 16, 2018 | K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 9, 2017 | K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | MDB | Substantially Equivalent | Becton Dickinson | accessdata.fda.gov |
| August 8, 2016 | K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | MDB | Substantially Equivalent | Becton Dickinson | accessdata.fda.gov |
| February 25, 2016 | K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 13, 2015 | K152516 | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks | JTN | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 10, 2014 | K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 13, 2013 | K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| March 16, 2012 | K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 18, 2011 | K112586 | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) | JTN | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| May 12, 2008 | K080998 | DORIPENEM 10UG BBL SENSI-DISC | JTN | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 17, 2005 | K052853 | TIGECYCLINE 15UG BBL SENSI-DISC | JTN | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 15, 2002 | K020842 | ERTAPENEM 10UG BBL SENSI-DISC | JTN | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| September 5, 2000 | K002165 | LINEZOLID, 30UG, BBL SENSI-DISC | JTN | Substantially Equivalent | Dickinson, and Co. | accessdata.fda.gov |
| April 25, 2000 | K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 1, 1999 | K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| January 28, 1998 | K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | MDB | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| July 28, 1997 | K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| March 6, 1997 | K970212 | LEVOFLOXACIN, 5MCG, SENSI-DISC | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| October 25, 1996 | K963845 | MEROPENEM, 10 MCG, SENSI-DISC | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| April 5, 1996 | K961188 | CEFEPIME, 30 MCG, SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 16, 1996 | K954925 | BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS | MDB | Substantially Equivalent | Becton Dickinson Diagnostic Instrument Systems | accessdata.fda.gov |
| October 27, 1994 | K943407 | GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| March 1, 1994 | K940359 | PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC | JTN | Substantially Equivalent | Becton Dickinson Microbiology Systems | accessdata.fda.gov |
| June 15, 1993 | K931374 | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST | MLA | Substantially Equivalent | Microprobe Corp. | accessdata.fda.gov |
| November 2, 1992 | K924797 | CEFPODOXIME 10 MCG, SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 30, 1992 | K920536 | AFFIRM VP SAMPLE COLLECTION SET | LIO | Substantially Equivalent | Microprobe Corp. | accessdata.fda.gov |
| May 8, 1992 | K921420 | AZITHROMYCIN, 15 MCG, SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 6, 1992 | K920131 | CLARITHROMYCIN 15MCG SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 4, 1991 | K910506 | OFLOXACIN, 5 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 2, 1990 | K895679 | CEFMATZOLE 30 MCG SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 14, 1989 | K893754 | CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 20, 1987 | K874425 | CIPROFLOXACIN 5 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 27, 1987 | K872783 | AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 17, 1987 | K864756 | NORFLOXACIN 10 MCG SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 13, 1987 | K865034 | AZTREONAM 30 MCG. SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 6, 1986 | K855106 | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | JTT | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 13, 1986 | K855135 | CEFACLOR SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 19, 1985 | K852873 | CEFTAZIDIME 30MCG. SENI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 21, 1985 | K851622 | TIMENTIN 85 MCG. SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 20, 1985 | K850358 | CEFTRIAXONE 30 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 23, 1984 | K842253 | AUGMENTIN 30 MCG SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| October 14, 1983 | K832515 | CEFUROXIME 30 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 9, 1983 | K831153 | CEFAXOLIN 30 MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 8, 1983 | K830732 | NETILMICIN 30 MCG SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| October 18, 1982 | K822832 | TICARCILLIN 75MCG. SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| June 22, 1982 | K821264 | CEFOPERAZONE 75MCG SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 31, 1981 | K813441 | PIPERACILLIN 100 MCG. SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 29, 1981 | K813387 | METRONIDAZOLE 80MCG. SENSI-DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 31, 1981 | K810564 | CEFOTAXIME 30 MCG. SENSI-DISC. | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| October 23, 1980 | K802194 | MINOCYCLINE 30MCG. SENSI DISC | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 13, 1980 | K801648 | TRIMETHROPRIM 5MCG. SENSI DISC. | JTN | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Susceptibility Test Discs, Antimicrobial
- All makers of System, Blood Culturing
- All makers of Dna Probe, Trichomonas Vaginalis
- All makers of Device, Specimen Collection
- All makers of System, Detection, Bacterial, For Platelet Transfusion Products
Updated March 24, 2023. 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.