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
2113–2136 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596 · JWY
Ab Biodisk
Microbiology · 90d
Cleared May 22, 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · JTN
Oxoid , Ltd.
Microbiology · 61d
Cleared May 22, 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
K993319 · LGD
bioMerieux, Inc.
Microbiology · 231d
Cleared May 18, 2000
ETEST MOXIFLOXACIN
K000298 · JWY
Ab Biodisk
Microbiology · 108d
Cleared May 15, 2000
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000928 · JTN
Oxoid , Ltd.
Microbiology · 54d
Cleared Apr 25, 2000
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
K000762 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 14, 2000
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
K000238 · LGC
Mrl Diagnostics
Microbiology · 78d
Cleared Apr 13, 2000
HARDYDISK, CEPHALOTHIN 30MCG
K000526 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 13, 2000
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
K000829 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Apr 07, 2000
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
K000261 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, AMPICILLIN, 10MCG
K000268 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, SULFA/TRIMETH
K000271 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK, NITROFURANTOIN
K000272 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Apr 07, 2000
HARDYDISK CEFTRIAXONE 30MCG
K000440 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 07, 2000
HARDYDISK, VANCOMYCIN 30MCG
K000509 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Apr 07, 2000
HARDYDISK, CEFOTAXIME 30MCG
K000524 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Apr 07, 2000
HARDYDISK OFLOXACIN 5MCG
K000525 · JTN
Hardy Diagnostics
Microbiology · 51d
Cleared Mar 31, 2000
HARDYDISK, CEFOXITIN, 30MCG
K000305 · JTN
Hardy Diagnostics
Microbiology · 59d
Cleared Mar 29, 2000
HARDYDISK, TETRACYCLINE 30MCG
K000304 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Mar 24, 2000
HARDY DISK, PENICILLIN, 10 UNITS
K000302 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Mar 21, 2000
HARDYDISK, KANAMYCIN, 30MCG
K000203 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 21, 2000
HARDYDISK, CIPROFLOXACIN, 5MCG
K000258 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
HARDYDISK, CEFTAZIDIME, 30MCG
K000259 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 07, 2000
SAS STREP A TEST
K993456 · GTY
Sa Scientific, Inc.
Microbiology · 146d