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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12097–12120 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 27, 1979
SYSTEM 103 CHEMISTRY ANALYZER
K792361 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 36d
Cleared Dec 27, 1979
TSH RADIOIMMUNOASSAY
K792443 · JLW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 27, 1979
REFEREE BFT BLOOD FOR TONOMETRY
K792447 · JJS
Analytical Products, Inc.
Chemistry · 27d
Cleared Dec 27, 1979
CHEM-STRATE CK-NAC
K792477 · CGS
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE CHOLESTEROL
K792478 · CHH
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE AMYLASE
K792479 · CIJ
General Diagnostics
Chemistry · 24d
Cleared Dec 27, 1979
CHEM-STRATE TRIGLYCERIDE
K792480 · CDT
General Diagnostics
Chemistry · 24d
Cleared Dec 18, 1979
LIPASE TEST KIT
K792289 · CET
Mallinckrodt Critical Care
Chemistry · 35d
Cleared Dec 18, 1979
STATTEK BUN
K792328 · CDN
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Dec 18, 1979
CONNECTICUT DIAGNOSTICS, LTS. DIRECT
K792465 · CIG
Connecticut Diagnostics, Ltd.
Chemistry · 15d
Cleared Dec 13, 1979
S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO
K792059 · JFH
S.F. Biologicals, Inc.
Chemistry · 59d
Cleared Dec 07, 1979
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · LBR
Sclavo, Inc.
Chemistry · 21d
Cleared Dec 07, 1979
ELVI CREATININE
K792397 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI GLUCOSE
K792398 · CGA
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI MAGNESIUM
K792399 · JGJ
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CHLORIDE
K792400 · CHJ
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI INORGANIC PHOSPHOROUS
K792401 · CEO
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININ
K792402 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININE
K792404 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · JFH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI SERUM IRON
K792406 · CFM
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID
K792412 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ALKALINE PHOSPHATATASE
K792413 · CJE
Volu Sol Medical Industries
Chemistry · 11d