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
1729–1752 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
K033458 · LON
Becton, Dickinson & CO
Microbiology · 211d
Cleared May 27, 2004
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL
K032897 · LLH
Ivd Research, Inc.
Microbiology · 253d
Not Cleared May 21, 2004
GLUCATELL
DEN040003 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 60d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · JJY
Bio-Rad Laboratories, Inc.
Microbiology · 50d
Cleared May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · LON
Becton, Dickinson & CO
Microbiology · 171d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K033907 · LON
Becton, Dickinson & CO
Microbiology · 114d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Dade Behring, Inc.
Microbiology · 317d
Cleared Apr 02, 2004
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · JWZ
Genzyme Corp.
Microbiology · 112d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Mar 18, 2004
IDI-MRSA
K033415 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 143d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Mar 09, 2004
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
K033861 · LQH
Becton, Dickinson & CO
Microbiology · 88d
Cleared Mar 02, 2004
CT OIA
K032330 · LJC
Thermo Biostar, Inc.
Microbiology · 217d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · LON
Becton, Dickinson & CO
Microbiology · 185d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Dade Behring, Inc.
Microbiology · 73d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · LLH
Remel, Inc.
Microbiology · 115d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · MIU
Wiener Laboratories Saic
Microbiology · 447d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 88d