Becton Dickinson Microbiology Systems
Cockeysville, MD, US
Becton Dickinson Microbiology Systems appears in FDA device records in Cockeysville, MD. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Becton Dickinson Microbiology Systems between 1992 and 1999. The busiest year on record is 1993, with 8. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 8 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 4 |
| 1997 | 6 |
| 1998 | 5 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | JTN | Substantially Equivalent | |
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY | LSL | Substantially Equivalent | |
| K981517 | CEFDINIR, 5 UG, SENSI-DISC | JTN | Substantially Equivalent | |
| K980683 | TROVAFLOXACIN 10G, SENSI-DISC | JTN | Substantially Equivalent | |
| K974578 | GREPAFLOXACIN, 5 MG, SENSI-DISC | JTN | Substantially Equivalent | |
| K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | MDB | Substantially Equivalent | |
| K970512 | BACTEC MYCO/F LYTIC CULTURE VIALS | MDB | Substantially Equivalent | |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | MDB | Substantially Equivalent | |
| K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | JTN | Substantially Equivalent | |
| K970385 | SPARFLOZACIN, 5 MCG, SENSI-DISC | JTN | Substantially Equivalent | |
| K970212 | LEVOFLOXACIN, 5MCG, SENSI-DISC | JTN | Substantially Equivalent | |
| K965159 | CETIBUTEN, 30MCG, SENSI-DISC | JTN | Substantially Equivalent | |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | LQL | Substantially Equivalent | |
| K963845 | MEROPENEM, 10 MCG, SENSI-DISC | JTN | Substantially Equivalent | |
| K963036 | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD | JTZ | Substantially Equivalent | |
| K962423 | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | JST | Substantially Equivalent | |
| K960420 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | JTZ | Substantially Equivalent | |
| K951539 | ENTEROCOCCUS SCREENING MEDIUM | JWY | Substantially Equivalent | |
| K950123 | SCEPTOR SYSTEM PANELS | JWY | Substantially Equivalent | |
| K944528 | BBLCRYSTAL ANAEROBE ID SYSTEM | JSP | Substantially Equivalent | |
| K945569 | GCII AGAR WITH ISOVITALX(R) ENRICHMENT | JSO | Substantially Equivalent | |
| K941997 | BBL CRYSTAL MRSA ID SYSTEM | JWY | Substantially Equivalent | |
| K943407 | GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS | JTN | Substantially Equivalent | |
| K940359 | PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC | JTN | Substantially Equivalent | |
| K932882 | GC II AGAR WITH ISOVITALEX | JSO | Substantially Equivalent | |
| K932879 | G C II AGAR WITH SENSIVITALEX | JSO | Substantially Equivalent | |
| K926294 | BBL CRYSTAL MRSA ID SYSTEM | JWY | Substantially Equivalent | |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | JSS | Substantially Equivalent | |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | JSS | Substantially Equivalent | |
| K926256 | BBL NINHYDRIN REAGENT DROPPERS | JTO | Substantially Equivalent | |
| K926255 | BBL NITRATE A, B REAGENT DROPPERS | JTO | Substantially Equivalent | |
| K926254 | BBL PYR REAGENT DROPPERS | JTO | Substantially Equivalent | |
| K923952 | ENOXACIN 10 MCG. SENSI SISC | JTN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LSLDna-Reagents, Neisseria
- LQLGram Positive Identification Panel
- JSPKit, Anaerobic Identification
- JSTKit, Fastidious Organisms
- JSSKit, Identification, Enterobacteriaceae
- JWYManual Antimicrobial Susceptibility Test Systems
- JTNSusceptibility Test Discs, Antimicrobial
- MDBSystem, Blood Culturing
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain