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
9001–9024 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 09, 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · KHE
Self Care Systems, Inc.
Chemistry · 162d
Cleared Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
K860640 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · JIR
Diagnostic Products Corp.
Chemistry · 369d
Cleared Apr 07, 1986
MARQUEST QC-IV TONOMETER
K855024 · JJS
Marquest Medical Products, Inc.
Chemistry · 111d
Cleared Apr 07, 1986
ACTHK-PR RIA KIT
K860311 · CKG
Compagnie Oris Industrie, S.A.
Chemistry · 69d
Cleared Apr 07, 1986
FLAME PHOTOMETER STANDARD
K860501 · JLJ
Medical Specialties, Inc.
Chemistry · 55d
Cleared Apr 07, 1986
ALPHA-AMYLASE TEST
K860665 · JFJ
Sclavo, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
K860668 · CGZ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
K860669 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K860723 · JPZ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
K860724 · CFR
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725 · CIT
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
K860727 · CKA
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
L D H-L (LACTIC DEHYDROGENASE) REAGENT
K860728 · CFJ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729 · CFJ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
K860730 · CDT
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · JGY
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Apr 07, 1986
AVL MODEL 983 ELECTROLYTE ANALYZER
K861087 · JGS
Avl Scientific Corp.
Chemistry · 17d
Cleared Apr 03, 1986
SGOT (AST) REAGENT SET
K860216 · CIQ
Sterling Diagnostics, Inc.
Chemistry · 71d