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
2377–2400 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 27, 1998
ETEST CEFTRIAXONE
K980345 · JWY
Ab Biodisk
Microbiology · 118d
Cleared May 27, 1998
ETEST TETRACYCLINE
K980347 · JWY
Ab Biodisk
Microbiology · 119d
Cleared May 18, 1998
CRYPTOSPORIDIUM TEST
K980354 · MHJ
Techlab, Inc.
Microbiology · 109d
Cleared May 18, 1998
ETEST GREPAFLOXACIN
K980773 · JWY
Ab Biodisk
Microbiology · 77d
Cleared May 18, 1998
PASCO MIC AND MIC/ID PANELS
K980955 · JTN
Pasco Laboratories, Inc.
Microbiology · 66d
Cleared May 13, 1998
ETEST TROVAFLOXACIN
K980603 · JWY
Ab Biodisk
Microbiology · 85d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076 · LYR
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared May 01, 1998
CMVGEN
K974456 · LJO
Instrumentation Laboratory CO
Microbiology · 157d
Cleared May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 122d
Cleared May 01, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · LLM
Clark Laboratories, Inc.
Microbiology · 73d
Cleared May 01, 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 67d
Cleared Apr 23, 1998
SERAQUEST MUMPS IGG
K980059 · LJY
Quest Intl., Inc.
Microbiology · 106d
Cleared Apr 23, 1998
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · GMZ
Alexon - Trend, Inc.
Microbiology · 72d
Cleared Apr 09, 1998
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW
Light Diagnostics
Microbiology · 142d
Cleared Apr 02, 1998
PARA-PAK SPINCON
K980077 · LKS
Meridian Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 26, 1998
EA-D IGG ELISA TEST SYSTEM
K973123 · LSE
Clark Laboratories, Inc.
Microbiology · 218d
Cleared Mar 20, 1998
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · MCB
Biosite Incorporated
Microbiology · 80d
Cleared Mar 17, 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · LYR
Shield Diagnostics, Ltd.
Microbiology · 218d
Cleared Mar 13, 1998
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM...
K971591 · LSQ
David C. Bishop, Ph.D.
Microbiology · 316d
Cleared Mar 10, 1998
PYLORI DETECT IGG
K973508 · LYR
Micro Detect, Inc.
Microbiology · 175d
Cleared Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · GTZ
Abbott Laboratories
Microbiology · 312d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · LYR
Boehringer Mannheim Corp.
Microbiology · 167d