FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1945–1968 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · MYI
Oxoid , Ltd.
Microbiology · 302d
Cleared Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · LON
bioMerieux, Inc.
Microbiology · 91d
Cleared Mar 27, 2002
MRSA-SCREEN
K011400 · MYI
Denka Seiken'S
Microbiology · 324d
Cleared Mar 27, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · LON
Becton, Dickinson & CO
Microbiology · 71d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · JWY
Dade Microscan, Inc.
Microbiology · 77d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · JWY
Pasco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS
K020142 · LON
Dade Behring, Inc.
Microbiology · 57d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
K020160 · LTT
Dade Behring, Inc.
Microbiology · 56d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared Mar 14, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020248 · LON
Dade Behring, Inc.
Microbiology · 49d
Cleared Mar 06, 2002
MICROSCAN SYNERGIES PLUS
K020511 · LON
Dade Microscan, Inc.
Microbiology · 19d
Cleared Feb 28, 2002
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K013819 · JTW
Sierra Diagnostic, LLC
Microbiology · 104d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Feb 19, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64...
K020328 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038 · LYR
Serim Research Corp.
Microbiology · 63d
Cleared Feb 06, 2002
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN...
K020168 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE...
K020173 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN...
K020182 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...
K020185 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...
K020209 · LON
Dade Behring, Inc.
Microbiology · 15d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...
K020246 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · LON
Dade Behring, Inc.
Microbiology · 13d