FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
409–432 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 24, 2022
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
K220801 · OZE
Abbott Diagnostics Scarborough, Inc.
Microbiology · 98d
Cleared Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 121d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · PBK
Centers For Disease Control and...
Microbiology · 2d
Cleared Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · PQA
Cepheid
Microbiology · 47d
Cleared Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test...
K220321 · QEP
Hologic, Inc.
Microbiology · 120d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · LON
bioMerieux, Inc.
Microbiology · 169d
Cleared May 20, 2022
Disposable Sampler Viral Transport Media
K211256 · JSM
Wuxi Nest Biotechnology Co., Ltd.
Microbiology · 389d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · LGD
Abbott Laboratories
Microbiology · 444d
Cleared May 10, 2022
BD CTGCTV2
K210585 · QEP
Becton, Dickinson and Company
Microbiology · 438d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · NJR
Cepheid
Microbiology · 535d
Cleared May 04, 2022
BioTeke Sterile Disposable Virus Sampling Kit
K211707 · JSM
Bioteke Corporation (Wuxi) Co., Ltd.
Microbiology · 335d
Cleared Apr 29, 2022
Alinity m STI Assay
K202977 · QEP
Abbott Molecular, Inc.
Microbiology · 576d
Not Cleared Apr 29, 2022
BioFire Joint Infection (JI) Panel
DEN200066 · QSN
Biofire Diagnostics, LLC
Microbiology · 549d
Cleared Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 209d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · LON
bioMerieux, Inc.
Microbiology · 113d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · GTY
Healgen Scientific, LLC
Microbiology · 210d
Cleared Mar 15, 2022
VITEK MS PRIME
K212461 · QBN
bioMerieux, Inc.
Microbiology · 221d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole...
K213241 · LON
bioMerieux, Inc.
Microbiology · 148d
Cleared Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · PQA
Cepheid
Microbiology · 209d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · LON
Biom?rieux, Inc.
Microbiology · 150d
Cleared Feb 02, 2022
NATtrol BD MAX Vaginal Panel External Controls
K201403 · PMN
Zeptometrix
Microbiology · 615d
Cleared Jan 19, 2022
MDx-Chex for BCID2
K212576 · PMN
Streck, Inc.
Microbiology · 156d
Cleared Dec 27, 2021
Colibri System
K193138 · QQV
Copan Wasp Srl
Microbiology · 775d
Cleared Dec 23, 2021
Curian Campy
K210976 · LQP
Meridian Bioscience, Inc.
Microbiology · 266d