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
8761–8784 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 11, 1986
MAGNESIUM PROCEDURE
K863267 · CFA
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 09, 1986
AMYLASE LTS
K862640 · CJA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 61d
Cleared Sep 09, 1986
ALP S.C.E.
K863051 · CJE
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
ALPHA AMYLASE
K863052 · CJA
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
BILIFAST
K863055 · CIG
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CLOROFAST
K863061 · CHJ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CHOLESTEROL-E FAST (TOTAL)
K863063 · CHH
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
PHOSPHOLIPIDS-E
K863071 · CEQ
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
FOSFOROMETER
K863072 · CEO
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL LIPIDS
K863073 · CFD
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
TOTAL PROTEINS
K863074 · CEK
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
UREAFAST
K863076 · CDL
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
CREATININE-E
K863078 · JFY
J. D. Assoc.
Chemistry · 28d
Cleared Sep 09, 1986
URICMETER
K863113 · KNK
J. D. Assoc.
Chemistry · 27d
Cleared Sep 09, 1986
BLOOD UREA NITROGEN(BUN) PROCEDURE
K863260 · CDQ
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Sep 08, 1986
CIBA CORNING MAGIC LITE ANALYZER
K862235 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 89d
Cleared Sep 03, 1986
ENZYMATIC BLOOD GLUCOSE
K862721 · CGA
U. S. Diagnostics, Inc.
Chemistry · 48d
Cleared Aug 29, 1986
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682 · CGA
Gambro, Inc.
Chemistry · 185d
Cleared Aug 29, 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Aug 29, 1986
AVL MODEL 984 ELECTROLYTE ANALYZER
K862819 · JGS
Avl Scientific Corp.
Chemistry · 36d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Aug 29, 1986
ALP (OPT) REAGENT
K862905 · CJE
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 16d