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
1849–1872 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 10, 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
K031059 · MHJ
Ivd Research, Inc.
Microbiology · 104d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
bioMerieux, Inc.
Microbiology · 66d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · LON
Becton, Dickinson & CO
Microbiology · 56d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · NOP
Panbio Limited
Microbiology · 5d
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