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
12961–12984 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 14, 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841 · CDT
Union Carbide Corp.
Chemistry · 66d
Cleared Jul 14, 1977
FLUCOSE U.V. TEST KIT
K770844 · CFR
Mallinckrodt Critical Care
Chemistry · 66d
Cleared Jul 14, 1977
ULTRAZYME PLUS ALP
K770870 · CJE
Harleco
Chemistry · 62d
Cleared Jul 14, 1977
ULTRAZYME PLUS HBD
K770871 · JMK
Harleco
Chemistry · 62d
Cleared Jul 14, 1977
ULTRAZYME PLUS GPT
K770882 · CKA
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
ULTRAZYME PLUS GOT
K770883
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
K770886 · CFR
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887 · CEK
Harleco
Chemistry · 59d
Cleared Jul 14, 1977
COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
K770902 · JKH
Sigma Chemical Co.
Chemistry · 59d
Cleared Jul 14, 1977
ENZYMATIC CHOLESTEROL REAGENT SET
K770909 · CHH
American Monitor Corp.
Chemistry · 56d
Cleared Jul 14, 1977
GLUTAMATE OXALACETIC TRANSAMINASE
K770917
The Dow Chemical Co.
Chemistry · 56d
Cleared Jul 12, 1977
TRIGLYCERIDE KIT
K771068 · JGM
Environmental Chemical Specialties
Chemistry · 29d
Cleared Jul 11, 1977
PIPETTE, DISPENSING, MODEL ADP-30SD
K770772 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
PIPETTE, DILUTING, MODEL ADP-30SD
K770773 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
LYTETEK SYSTEM
K770774 · JGT
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Jul 11, 1977
REAGENTS
K770780 · CHH
Chemetrics Corp.
Chemistry · 73d
Cleared Jul 11, 1977
SHAVE PREP SET
K770795 · JJX
Lukens Corp.
Chemistry · 70d
Cleared Jul 11, 1977
ULTRAZYME PLUS GT
K770815
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM ALBUMIN
K770816 · CIX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CALCIUM
K770817 · CJY
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRAZYME PLUS, LDH
K770818 · CFJ
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CREATININE
K770819 · CGX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM INORGANIC PHOSPHORUS
K770820 · CEO
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
A-GENT ALBUMIN
K770822 · CIX
Abbott Laboratories
Chemistry · 68d