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
9937–9960 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · LCX
Organon, Inc.
Chemistry · 34d
Cleared May 22, 1984
BLOOD SPOT NEONATAL TSH RADIOIMMUNO
K841606 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 33d
Cleared May 22, 1984
INNOFLUOR PHENYTOIN
K841706 · LGR
Innotron Diagnostics
Chemistry · 29d
Cleared May 21, 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · DGC
Pharmacia, Inc.
Chemistry · 108d
Cleared May 21, 1984
CAPILLARY GAS CHROMATOGRAPHIC COLUMNS
K841712 · DII
Supelco, Inc.
Chemistry · 27d
Cleared May 16, 1984
UNIPAK 100 ANALYZER, 65156 & CHEMISTR
K840883 · JJE
Emd Chemicals, Inc.
Chemistry · 79d
Cleared May 16, 1984
POTASSIUM CHLORIDE SOLUTION -2 MOLAR
K841417 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
SODIUM ELECTRODE RINSE SOLUTION 2
K841418 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
CORNING LACTATE DEHYDROPHORETIC ASSAY
K841433 · CFE
Corning Medical & Scientific
Chemistry · 40d
Cleared May 16, 1984
TOTAL PROTEIN REAGENT BIURET
K841466 · CEK
Reagents Applications, Inc.
Chemistry · 37d
Cleared May 16, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 37d
Cleared May 16, 1984
DIRECT BILIRUBIN REAGENT
K841572 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared May 16, 1984
INSULIN RADIOIMMUNOASSAY KIT
K841573 · CFP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 29d
Cleared May 14, 1984
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
K834270 · LCX
Advanced Care Products
Chemistry · 158d
Cleared May 14, 1984
YD STRIP GP U20
K834386 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
YD STRIP GPH U21
K834387 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
KYOTEST 5V
K840827 · CEN
Kyoto Diagnostics, Inc.
Chemistry · 80d
Cleared May 11, 1984
YD STRIP GLUCOSE U19
K834385 · JIL
Yd Pharmaceutical Corp.
Chemistry · 149d
Cleared May 11, 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · CFT
Abbott Laboratories
Chemistry · 57d
Cleared May 11, 1984
ULTRACLONE ECL-01-900 CELL LINE
K841340 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-1000 CELL LINE
K841341 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-400 CELL LINE
K841342 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-100 CELL LINE
K841343 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-300 CELL LINE
K841344 · KIR
Earl-Clay Laboratories, Inc.
Chemistry · 39d