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
8497–8520 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 10, 1987
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · CGJ
Hybritech, Inc.
Chemistry · 32d
Cleared Mar 06, 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Mar 06, 1987
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K870077 · CIT
Catachem, Inc.
Chemistry · 57d
Cleared Mar 06, 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · CKA
Catachem, Inc.
Chemistry · 57d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Mar 06, 1987
WAKO(TM) AUTOKIT LDH
K870401 · CFJ
Wako Chemicals USA, Inc.
Chemistry · 32d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · JIL
American Diagnostic Corp.
Chemistry · 30d
Cleared Mar 06, 1987
SUPER URINE ANALYZER SYSTEM
K870526 · KQO
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 28d
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Mar 06, 1987
GLUCOSE OXIDASE REAGENT
K870616 · CGA
Intersect Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Feb 26, 1987
ISE COMPENSATION SERA
K870379 · JIS
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · CGA
Lifescan, Inc.
Chemistry · 114d
Cleared Feb 25, 1987
710 PLUS
K864557 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Feb 25, 1987
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · JLS
Amersham Corp.
Chemistry · 76d
Cleared Feb 25, 1987
SMI DIGITRON
K870406 · JQW
American Dade
Chemistry · 22d
Cleared Feb 20, 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · JFJ
Data Medical Associates, Inc.
Chemistry · 73d
Cleared Feb 20, 1987
OLYMPUS PK300
K864834 · JJF
Olympus Corp.
Chemistry · 73d
Cleared Feb 20, 1987
REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
K864862 · JGS
Hf Scientific, Inc.
Chemistry · 71d
Cleared Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · CDT
Sigma Diagnostics, Inc.
Chemistry · 49d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 38d