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
1945–1968 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020321 · LON
Becton, Dickinson & CO
Microbiology · 128d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939 · LTT
Dade Microscan, Inc.
Microbiology · 56d
Cleared May 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K020398 · LON
Dade Behring, Inc.
Microbiology · 99d
Cleared May 15, 2002
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · JTN
Becton, Dickinson & CO
Microbiology · 61d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627 · LTT
Dade Microscan, Inc.
Microbiology · 69d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · JWY
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared May 01, 2002
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
K020576 · NIJ
Id Biomedical Corp.
Microbiology · 69d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL -...
K020686 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · JWY
Ab Biodisk
Microbiology · 53d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · JWY
Dade Microscan, Inc.
Microbiology · 65d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · LTT
Dade Microscan, Inc.
Microbiology · 59d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN...
K020397 · LON
Dade Behring, Inc.
Microbiology · 75d
Cleared Apr 19, 2002
BACTEC MGIT 960 SIRE KITS
K014123 · MJA
Becton, Dickinson & CO
Microbiology · 123d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · MDB
bioMerieux, Inc.
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · MDB
bioMerieux, Inc.
Microbiology · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · MDB
bioMerieux, Inc.
Microbiology · 27d