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
2857–2880 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 02, 1996
SAS SALMONELLA H F,G, ANTISERUM
K955210 · GNC
Sa Scientific, Inc.
Microbiology · 80d
Cleared Jan 30, 1996
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · LIN
Biotest Diagnostics Corp.
Microbiology · 301d
Cleared Jan 30, 1996
DRYSIDE NEISSERIA
K954784 · LTS
Difco Laboratories, Inc.
Microbiology · 105d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926 · LYR
E-Z-Em, Inc.
Microbiology · 96d
Cleared Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · GTZ
Abbott Laboratories
Microbiology · 220d
Cleared Jan 17, 1996
COLORSLIDER RUBELLA
K952544 · LQN
Seradyn, Inc.
Microbiology · 229d
Cleared Jan 11, 1996
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
K940564 · LJC
Dako Diagnostics , Ltd.
Microbiology · 707d
Cleared Dec 26, 1995
ESP CULTURE SYSTEM - MYCO
K953129 · MDB
Difco Laboratories, Inc.
Microbiology · 173d
Cleared Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · LGD
Bio-Rad Laboratories, Inc.
Microbiology · 264d
Cleared Dec 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
K954515 · GOM
Pyramid Biological Corp.
Microbiology · 83d
Cleared Dec 20, 1995
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · JTO
Microbiologics, Inc.
Microbiology · 62d
Cleared Dec 18, 1995
SERIM PYLORITEK TEST KIT
K953632 · LYR
Serim Research Corp.
Microbiology · 151d
Cleared Dec 14, 1995
ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
K953826 · GOM
Pyramid Biological Corp.
Microbiology · 121d
Cleared Dec 12, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · JWY
Ab Biodisk
Microbiology · 90d
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · MKZ
Abbott Laboratories
Microbiology · 802d
Cleared Nov 20, 1995
TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
K952467 · MHI
Trend Scientific, Inc.
Microbiology · 178d
Cleared Nov 20, 1995
MRC-5 CELL CULTURE VIAL
K952727 · KIR
Viratest Intl., Inc.
Microbiology · 159d
Cleared Nov 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
K952818 · GMM
Pyramid Biological Corp.
Microbiology · 153d
Cleared Nov 20, 1995
GIBSON ID A.E. TEST
K953247 · JTO
Gibson Laboratories, Inc.
Microbiology · 132d
Cleared Nov 16, 1995
CMV IGG HUMAN SERUM CONTROLS
K951800 · GQI
Pyramid Biological Corp.
Microbiology · 212d
Cleared Nov 16, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · GQI
Pyramid Biological Corp.
Microbiology · 185d
Cleared Nov 16, 1995
MID-STREAM COLLECTION SET-STERILE
K953929 · LIO
Trinity Laboratories, Inc.
Microbiology · 87d
Cleared Nov 14, 1995
PREMIER EHEC
K953362 · GNA
Meridian Diagnostics, Inc.
Microbiology · 120d
Cleared Nov 01, 1995
VIROTROL IV
K954298 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 48d