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
1993–2016 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 24, 2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
K010892 · LSK
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
K010893 · LSL
Digene Corp.
Microbiology · 182d
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · LSL
Becton, Dickinson & CO
Microbiology · 55d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · JJX
Ortho-Clinical Diagnostics
Microbiology · 21d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · LTT
Dade Behring, Inc.
Microbiology · 191d
Cleared Aug 20, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · LGD
Bayer Corp.
Microbiology · 160d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Jul 31, 2001
COPAN VIRAL TRANSYSTEM
K001780 · JSM
Copan Diagnostics, Inc.
Microbiology · 413d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · LTT
Dade Microscan, Inc.
Microbiology · 191d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · MSQ
Oridion Medical 1987 , Ltd.
Microbiology · 53d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · LFX
Bayer Corp.
Microbiology · 121d
Cleared Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K003259 · LGD
Beckman Coulter, Inc.
Microbiology · 238d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d
Cleared Jun 11, 2001
IMMUNOWELL EA (D) IGG TEST
K010301 · LSE
Genbio
Microbiology · 130d
Cleared Jun 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · MJA
Bd Becton Dickinson Vacutainer...
Microbiology · 247d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761 · LIO
Medical Packaging Corp.
Microbiology · 176d
Cleared May 24, 2001
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K010858 · MYI
Id Biomedical Corp.
Microbiology · 63d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · LSL
Gen-Probe, Inc.
Microbiology · 201d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Hardy Diagnostics
Microbiology · 11d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754 · LSR
Immunetics, Inc.
Microbiology · 156d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · GTY
Quidel Corp.
Microbiology · 27d