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
5377–5400 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 02, 1994
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
K944452 · JJY
Beckman Instruments, Inc.
Chemistry · 81d
Cleared Dec 02, 1994
PHOSPHORUS TEST (PHOS)
K945368 · CEO
Emd Chemicals, Inc.
Chemistry · 43d
Cleared Nov 30, 1994
PROCHEM CHEMISTRY ANALYZER
K944028 · JJE
Prisma Systems
Chemistry · 105d
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361 · JJX
Casco Standards
Chemistry · 84d
Cleared Nov 28, 1994
ACE CEDIA CORTISOL ASSAY
K943427 · CGR
Schiapparelli Biosystems, Inc.
Chemistry · 136d
Cleared Nov 28, 1994
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · JJQ
Instrumentation Laboratory CO
Chemistry · 126d
Cleared Nov 22, 1994
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
K933414 · KHQ
Baxter Diagnostics, Inc.
Chemistry · 497d
Cleared Nov 22, 1994
BILIRUBIN (DIRECT) QVET
K942949 · CIG
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
TRIGLYCERODES QVET
K942998 · CDT
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
CREATININE QVET
K943005 · CGX
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
ALT QVET
K944080 · CKA
Prisma Systems
Chemistry · 92d
Cleared Nov 22, 1994
QUANTITATE URIC ACID VERIFIER SET
K944453 · JJX
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Nov 21, 1994
CREATINE KINASE MB DETERMINATION (UV)
K942958 · JHW
Biochemical Trade, Inc.
Chemistry · 151d
Cleared Nov 21, 1994
CALIBRATORS
K944701 · JIS
Diagnostic Reagents, Inc.
Chemistry · 59d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083 · JHS
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Nov 17, 1994
VERDICT COCAINE
K943710 · DIO
Editek, Inc.
Chemistry · 108d
Cleared Nov 17, 1994
ISOSCAN
K944185 · JQT
Isolab, Inc.
Chemistry · 83d
Cleared Nov 17, 1994
SERUM PROTEIN CONTROLS
K944515 · JJX
Pyramid Biological Corp.
Chemistry · 63d
Cleared Nov 17, 1994
SAS QUANT HCG URINE
K944891 · JJX
Sa Scientific, Inc.
Chemistry · 44d
Cleared Nov 15, 1994
ANGIOTENSIN CONVERTING ENZYME REA
K942497 · KQN
American Laboratory Products Co., Ltd.
Chemistry · 182d
Cleared Nov 15, 1994
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
K944338 · JJX
Casco Standards
Chemistry · 70d
Cleared Nov 15, 1994
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
K944639 · JIX
Casco Standards
Chemistry · 55d
Cleared Nov 14, 1994
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
K944202 · JGJ
Abbott Laboratories
Chemistry · 95d
Cleared Nov 10, 1994
REP DIRECT-SEP CHOLESTEROL-15 KIT
K935162 · JHO
Helena Laboratories
Chemistry · 377d