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
9553–9576 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 07, 1985
BCS POTASSIUM TURBIDIMETRIC TEST
K850258 · CEJ
Bioclinical Systems, Inc.
Chemistry · 16d
Cleared Feb 06, 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · JJY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Feb 06, 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · JLS
Leeco Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 06, 1985
CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY
K850140
Corning Medical & Scientific
Chemistry · 23d
Cleared Feb 06, 1985
ACTIVE CORTISOL DSL 2000-SP
K850141 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared Feb 06, 1985
GELMAN TRIPHOR CONTROL
K850202 · JJY
Gelman Sciences, Inc.
Chemistry · 19d
Cleared Feb 06, 1985
CALCIUM
K850281 · CIC
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Feb 04, 1985
CORNING CALCIUM PH ANALYZER 634
K844188 · JFP
Corning Medical & Scientific
Chemistry · 101d
Cleared Feb 04, 1985
VISION TRIGLYCERIDES
K850031 · CDT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 01, 1985
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
K844767 · CGI
Biotecx Laboratories, Inc.
Chemistry · 56d
Cleared Feb 01, 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781 · CHL
Shaban Mfg. Co.
Chemistry · 53d
Cleared Feb 01, 1985
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
K845026 · JLS
Amersham Corp.
Chemistry · 36d
Cleared Feb 01, 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · CGR
Diagnostic Products Corp.
Chemistry · 30d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · CJE
Abbott Laboratories
Chemistry · 15d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Jan 23, 1985
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · JHJ
Fisher Diagnostics
Chemistry · 75d
Cleared Jan 18, 1985
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
K844066 · CGJ
Clinetics Corp.
Chemistry · 92d
Cleared Jan 18, 1985
TDX TOTAL ESTRIOL
K844511 · CGI
Abbott Laboratories
Chemistry · 59d
Cleared Jan 18, 1985
MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI
K844559 · JGS
Thermo Orion
Chemistry · 58d
Cleared Jan 18, 1985
AVL MODEL 982 ELECTROLYTE ANALYZER
K844587 · JGS
Avl Scientific Corp.
Chemistry · 56d
Cleared Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · JQP
Miles Laboratories, Inc.
Chemistry · 32d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · CDO
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 23d