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
793–816 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 10, 2017
TRI-COMBO PARASITE SCREEN
K171078 · MHJ
Techlab, Inc.
Microbiology · 90d
Cleared Jun 29, 2017
Rickettsia Real-time PCR Assay
K170940 · PVQ
Centers For Disease Control and...
Microbiology · 91d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · LGD
Roche Diagnostics
Microbiology · 270d
Cleared Jun 22, 2017
FilmArray NGDS Warrior Panel
K170883 · PRD
Biofire Defense, LLC
Microbiology · 90d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737 · LON
bioMerieux, Inc.
Microbiology · 264d
Cleared Jun 15, 2017
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · OQO
Hologic, Inc.
Microbiology · 262d
Cleared Jun 09, 2017
ePlex Instrument
K163652 · NSU
Genmark Diagnostics, Incorporated
Microbiology · 168d
Cleared Jun 09, 2017
ePlex Respiratory Pathogen Panel
K163636 · OCC
Genmark Diagnostics, Incorporated
Microbiology · 169d
Cleared Jun 07, 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
K170772 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared Jun 07, 2017
E. HISTOLYTICA QUIK CHEK
K170728 · KHW
Techlab, Inc.
Microbiology · 90d
Cleared Jun 01, 2017
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT...
K170652 · PRI
Fisher Diagnostics
Microbiology · 90d
Cleared May 31, 2017
B R A H M S PCT sensitive KRYPTOR
K171338 · PRI
Brahms GmbH
Microbiology · 23d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · JWY
bioMerieux, Inc.
Microbiology · 86d
Cleared May 30, 2017
FilmArray Respiratory Panel 2 (RP2)
K170604 · OCC
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared May 25, 2017
revogene
K170558 · OOI
Genepoc, Inc.
Microbiology · 90d
Cleared May 25, 2017
GenePOC GBS LB
K170557 · NJR
Genepoc, Inc.
Microbiology · 90d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · PQZ
Hardy Diagnostics
Microbiology · 83d
Cleared May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...
K170509 · PUQ
Bio-Rad Laboratories
Microbiology · 87d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481 · PQZ
Hardy Diagnostics
Microbiology · 89d
Cleared May 11, 2017
Solana C. difficile Assay
K170491 · OZN
Quidel Corporation
Microbiology · 83d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...
K170413 · LIP
Bio-Rad Laboratories
Microbiology · 90d
Cleared May 02, 2017
BD MAX Extended Enteric Bacterial Panel, BD MAX System
K170308 · PCH
Becton, Dickinson and Company
Microbiology · 90d
Cleared CT May 02, 2017
ARIES Bordetella Assay
K163626 · OZZ
Luminex Corporation
Microbiology · 131d