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
433–456 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS...
K213899 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Jul 11, 2022
Revogene
K220480 · OOI
Meridian Bioscience, Inc.
Microbiology · 143d
Cleared Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
K213822 · OCC
Roche Molecular Systems, Inc.
Microbiology · 210d
Cleared Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834 · PBK
Centers For Disease Control and...
Microbiology · 1d
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