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
2425–2448 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · MSQ
Alimenterics, Inc.
Microbiology · 198d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676 · JXA
Combact Diagnostic Systems , Ltd.
Microbiology · 222d
Cleared Feb 23, 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 77d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · JJY
Casco Standards
Microbiology · 198d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 12, 1998
PASCO MIC AND MIC/ID PANELS
K974362 · JWY
Pasco Laboratories, Inc.
Microbiology · 85d
Cleared Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811 · JJX
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Jan 28, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970333 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 365d
Cleared Jan 28, 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · JTN
Oxoid , Ltd.
Microbiology · 271d
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552 · LJB
Diamedix Corp.
Microbiology · 55d
Cleared Jan 27, 1998
VIROTROL III
K974613 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 47d
Cleared Jan 22, 1998
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · LQL
Accumed Intl., Inc.
Microbiology · 196d
Cleared Jan 14, 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · JTN
Oxoid , Ltd.
Microbiology · 55d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 331d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304 · LFX
Inova Diagnostics, Inc.
Microbiology · 269d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · GMZ
Shared Systems, Inc.
Microbiology · 112d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663 · GMZ
Murex Biotech , Ltd.
Microbiology · 238d