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: Chemistry ×
13,237 results
5137–5160 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 13, 1995
DADE STRATUS TROPONIN-I CONTROL
K951888 · JJX
Dade Intl., Inc.
Chemistry · 80d
Cleared Jul 13, 1995
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS...
K951890 · MMI
Dade Intl., Inc.
Chemistry · 80d
Cleared Jul 11, 1995
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
K946274 · LCP
Helena Laboratories
Chemistry · 200d
Cleared Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · CDD
Microgenics Corp.
Chemistry · 120d
Cleared Jul 11, 1995
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
K951538 · CEP
Syntron Bioresearch, Inc.
Chemistry · 99d
Cleared Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · JJS
Nova Biomedical Corp.
Chemistry · 37d
Cleared Jul 03, 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · CGA
Lifescan, Inc.
Chemistry · 131d
Cleared Jul 03, 1995
AMERLITE FSH ASSAY
K952285 · CGJ
Johnson & Johnson Clinical...
Chemistry · 48d
Cleared Jul 03, 1995
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)
K952505 · CFL
Nichols Institute
Chemistry · 33d
Cleared Jun 30, 1995
HYDRAGEL PROTEIN(E) KIT
K951536 · CEF
Sebia
Chemistry · 88d
Cleared Jun 30, 1995
LOK-ON NEEDLE DISPOSAL SYSTEM
K951886 · GIM
Becton Dickinson Vacutainer Systems
Chemistry · 67d
Cleared Jun 29, 1995
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
K950588 · KLI
Biomerica, Inc.
Chemistry · 140d
Cleared Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · CGN
Microgenics Corp.
Chemistry · 107d
Cleared Jun 29, 1995
SYNCHRON ENZYME VALIDATOR SET
K951964 · JIS
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
K952148 · JLW
Abbott Laboratories
Chemistry · 52d
Cleared Jun 23, 1995
IGFBP-3
K946247 · CFL
Nichols Institute
Chemistry · 183d
Cleared Jun 20, 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · LGS
Ciba Corning Diagnostics Corp.
Chemistry · 97d
Cleared Jun 20, 1995
SYNERMED ISE REAGENTS
K952179 · JGS
Synermed, Inc.
Chemistry · 42d
Cleared Jun 20, 1995
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
K952246 · JXA
Tri-Tech, Inc.
Chemistry · 39d
Cleared Jun 20, 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · JHI
Medix Biotech, Inc.
Chemistry · 33d
Cleared Jun 19, 1995
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
K951332 · CKA
Dade Intl., Inc.
Chemistry · 102d
Cleared Jun 19, 1995
ELI URINE CONTROLS
K951817 · DIF
Elsohly Labs, Inc.
Chemistry · 60d
Cleared Jun 15, 1995
T-UPTAKE CALIBRATORS
K951585 · JIS
Diagnostic Reagents, Inc.
Chemistry · 70d
Cleared Jun 14, 1995
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
K950234 · CEK
Emd Chemicals, Inc.
Chemistry · 152d