Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1969–1992 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE...
K020506 · LON
Dade Microscan, Inc.
Microbiology · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
bioMerieux, Inc.
Microbiology · 35d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · LON
Becton, Dickinson & CO
Microbiology · 79d
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