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
12913–12936 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 10, 1977
LDH-INT TEST
K771343 · CFH
Hycel, Inc.
Chemistry · 21d
Cleared Aug 10, 1977
TRANSPORTEO MODULE
K771446 · JQX
Hyland Therapeutic Div., Travenol...
Chemistry · 9d
Cleared Aug 04, 1977
CARDIOZYME CK-CONTROL ABNORMAL
K770971 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
CARDIOZYME CK CONTROL NORMAL
K770973 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR
K771033 · CKA
Mid Tech, Inc.
Chemistry · 56d
Cleared Aug 04, 1977
DYNAZYME II Y-GT
K771084
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · CJE
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
AUTO-LOGIC II SYSTEM
K771129 · JJJ
Abbott Laboratories
Chemistry · 42d
Cleared Aug 04, 1977
PIPETS UNIFORM DROP SIZE BOROSILICATE
K771137 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
PIPETS BOROSILICATE GLASS
K771138 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
T3 RIA TEST SYSTEM
K771220 · CDP
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
T4 RIA TEST SYSTEM
K771221 · CDX
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
TSH RIA TEST SYSTEM
K771222 · JLW
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
BICHROMATIC ANALYZER ABA-200
K771345 · JJE
Abbott Laboratories
Chemistry · 15d
Cleared Aug 03, 1977
AP ISOTROL, #A 0140
K771225 · CIN
Sigma Chemical Co.
Chemistry · 29d
Cleared Aug 03, 1977
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · JLW
Abbott Laboratories
Chemistry · 23d
Cleared Aug 03, 1977
RIA FOR TOTAL THYROXINE
K771309 · CDX
Abbott Laboratories
Chemistry · 16d
Cleared Aug 03, 1977
CALCIUM REAGENT
K771310 · CIC
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (HEXOHINASE)
K771311 · CFR
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · CDW
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CHOLESTEROL REAGENT
K771313 · CGO
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (O-TOLUIDINE)
K771314 · CGE
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CREATININE ANALYZER 2
K771335 · CGX
Beckman Instruments, Inc.
Chemistry · 16d
Cleared Aug 02, 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991 · CKA
Macomb Chemical Co.
Chemistry · 62d