FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12457–12480 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · CGS
Sigma Chemical Co.
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · JBQ
Ortho Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865 · JIY
Stanbio Laboratory
Chemistry · 28d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Kallestad Laboratories, Inc.
Chemistry · 27d
Cleared Dec 04, 1978
MINIWASH
K781942 · JTC
Dynatech Laboratories, Inc.
Chemistry · 17d
Cleared Nov 22, 1978
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · CJM
Abbott Laboratories
Chemistry · 84d
Cleared Nov 22, 1978
RIA, CORTISOL KIT
K781730 · CGR
Radioassay Systems Laboratories, Inc.
Chemistry · 40d
Cleared Nov 22, 1978
REAGENT, HDL
K781740 · CHH
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Nov 22, 1978
LDH REAGENT SYSTEM
K781765 · CFJ
American Monitor Corp.
Chemistry · 37d
Cleared Nov 22, 1978
TOTAL PROTEIN
K781774 · CEK
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 22, 1978
LDH
K781775 · CFJ
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 15, 1978
HEMACHECK
K781562 · GKL
Vickers America Medical Corp.
Chemistry · 65d
Cleared Nov 15, 1978
CALIBRATOR, BOVINE SERUM
K781702 · JIX
Bio-Reagents & Diagnostics, Inc.
Chemistry · 36d
Cleared Nov 08, 1978
ACCUSCREEN T4
K781222 · CDX
Neometrics, Inc.
Chemistry · 114d
Cleared Nov 08, 1978
RIA, T3 UPTAKE SOLID PHASE
K781662 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 41d
Cleared Nov 03, 1978
ALP REAGENT SET, ALKALINE PHOSPHATASE
K781718 · CJE
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
CPK REAGENT SET, NAD REDUCTION
K781719 · CGS
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
HBDH ENZYME KINETIC REAGENT SET
K781720 · JMK
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, CHOLESTEROL
K781721 · CHH
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, TOTAL PROTEIN
K781722 · CEK
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
GLUCOSE HEXOKINASE, AUTO K
K781723 · CFR
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
NAD REDUCTION METHOD, LACTATE PYRIVATE
K781724 · CFJ
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725 · CIT
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, SGPT SERUM GLUTAMIC
K781726 · CKA
Medical Analysis Systems, Inc.
Chemistry · 23d