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
1849–1872 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 77d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · MHI
Ivd Research, Inc.
Microbiology · 82d
Cleared Feb 28, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
K030091 · LON
Bd Diagnostic Systems
Microbiology · 49d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · JWZ
Xenotope Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 10, 2003
ACON STREP A TWIST TEST DEVICE
K023766 · GTY
Acon Laboratories Co.
Microbiology · 90d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · GQG
Sa Scientific, Inc.
Microbiology · 155d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · LIB
Osmetech
Microbiology · 89d
Cleared Jan 24, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023568 · LON
Becton, Dickinson & CO
Microbiology · 92d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · MJX
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Jan 14, 2003
RSV OIA
K023779 · GQG
Thermo Biostar, Inc.
Microbiology · 63d
Cleared Jan 08, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · GMZ
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Dec 24, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Dec 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
K023527 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Dec 20, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023858 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN...
K023361 · LON
Dade Behring, Inc.
Microbiology · 70d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · GQG
Becton, Dickinson & CO
Microbiology · 162d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · GQG
Integrated Biotechnology Corp.
Microbiology · 173d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · NJR
Infectio Diagnostic, Inc.
Microbiology · 112d