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
1825–1848 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · LSE
Panbio Limited
Microbiology · 101d
Cleared Jun 24, 2003
BD VIPER INSTRUMENT
K023955 · JQW
Becton, Dickinson & CO
Microbiology · 209d
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · LFX
Beckman Coulter, Inc.
Microbiology · 29d
Not Cleared Jun 16, 2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
DEN030002 · NGS
Spectral Diagnostics, Inc.
Microbiology · 63d
Cleared Jun 13, 2003
PASCO MIC AND MIC/ID PANELS
K031205 · JWY
Pasco Laboratories, Inc.
Microbiology · 58d
Cleared Jun 12, 2003
PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
K031103 · JWY
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · LYR
Alfa Scientific Designs, Inc.
Microbiology · 162d
Cleared Jun 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
K031429 · LON
Bd Diagnostic Systems
Microbiology · 31d
Cleared Jun 02, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE
K031306 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · LGD
Beckman Coulter, Inc.
Microbiology · 19d
Cleared May 16, 2003
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
K023857 · NOM
Bio-Rad
Microbiology · 177d
Cleared May 16, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
K030986 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared May 06, 2003
KALAZAR DETECT
K023483 · LOO
Inbios Intl., Inc.
Microbiology · 201d
Cleared May 01, 2003
PASCO MIC AND MIC/ID PANELS
K030933 · JWY
Pasco Laboratories, Inc.
Microbiology · 37d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404 · LLH
Techlab, Inc.
Microbiology · 77d
Cleared Apr 17, 2003
GC OIA
K023947 · LIR
Thermo Biostar, Inc.
Microbiology · 141d
Cleared Apr 14, 2003
URINE MONOVETTE BORIC ACID
K024237 · JSM
Sarstedt, Inc.
Microbiology · 112d
Cleared Apr 14, 2003
PASCO MIC AND MIC/ID PANELS
K030620 · LTT
Pasco Laboratories, Inc.
Microbiology · 46d
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · LYR
ACON Laboratories, Inc.
Microbiology · 93d
Cleared Apr 01, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
K030677 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Mar 27, 2003
FLU OIA A/B TEST KIT
K023556 · PSZ
Thermo Biostar, Inc.
Microbiology · 155d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · LYR
Inova Diagnostics, Inc.
Microbiology · 91d
Cleared Mar 26, 2003
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
K024240 · JSM
Bd
Microbiology · 93d
Cleared Mar 21, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
K030579 · LON
Becton, Dickinson & CO
Microbiology · 25d