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
313–336 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared Nov 15, 2023
Simple 2 Test
DEN200070 · QYA
Letsgetchecked Inc. (Formerly...
Microbiology · 1094d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · OZN
Vela Operations USA
Microbiology · 124d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · QYT
ACON Laboratories, Inc.
Microbiology · 227d
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316 · OUY
Hologic, Inc.
Microbiology · 182d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · LFY
DiaSorin, Inc.
Microbiology · 182d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
K232201 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · PQA
Cepheid
Microbiology · 160d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d
Cleared Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 67d
Cleared Oct 05, 2023
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
K232395 · JWY
Biom?rieux
Microbiology · 57d
Cleared Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
K212769 · OPL
Dynex Technologies, Inc.
Microbiology · 759d
Cleared Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013 · QBD
Zymo Research
Microbiology · 171d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · NJR
Cepheid
Microbiology · 391d
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG...
K213987 · MXJ
Biokit, S.A.
Microbiology · 639d
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336 · QVR
T2biosystems, Inc.
Microbiology · 130d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563 · QQV
Becton, Dickinson and Company
Microbiology · 372d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K231988 · JWY
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · QOF
Cepheid
Microbiology · 86d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d