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
9649–9672 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032 · CDT
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 09, 1984
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
K844047 · JIT
Fisher Diagnostics
Chemistry · 23d
Cleared Nov 09, 1984
INORGANIC PHOSPHORUS REAGENT SET
K844182 · CEO
Livonia Diagnostics, Inc.
Chemistry · 14d
Cleared Nov 05, 1984
ROCHE REAGENT FOR AST
K843109 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Nov 02, 1984
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · JLW
Abbott Laboratories
Chemistry · 56d
Cleared Nov 02, 1984
HDL PRECIPATATING REAGENT SET
K843894 · LBR
Livonia Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 31, 1984
RAICHEM X-HBDH REAGENT
K843774 · JMK
Reagents Applications, Inc.
Chemistry · 36d
Cleared Oct 31, 1984
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872 · DKC
Sigma Chemical Co.
Chemistry · 29d
Cleared Oct 31, 1984
AO-10 AUTOMATED OSMOMETER
K843997 · JJM
bioMerieux, Inc.
Chemistry · 20d
Cleared Oct 30, 1984
BETA QUIK V
K843795 · JHI
Pacific Biotech, Inc.
Chemistry · 33d
Cleared Oct 30, 1984
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
MAGNESIUM REAGENT SET
K843893 · JGJ
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
TOTAL CALCIUM REAGENT SET
K843895 · CIC
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
TDX REA CREATININE
K843916 · CGX
Abbott Laboratories
Chemistry · 25d
Cleared Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
K843938 · KNK
Simmler, Inc.
Chemistry · 21d
Cleared Oct 30, 1984
FOCUS URIC ACID
K844011 · KNK
Abbott Laboratories
Chemistry · 18d
Cleared Oct 30, 1984
CREATININE REAGENT SET
K844024 · CGX
Livonia Diagnostics, Inc.
Chemistry · 15d
Cleared Oct 30, 1984
URIC ACID REAGENT SET
K844075 · LFQ
Livonia Diagnostics, Inc.
Chemistry · 11d
Cleared Oct 25, 1984
DIAGNOSTIC MICROSOPCE SLIDES
K844092
Sybron Corp.
Chemistry · 6d
Cleared Oct 22, 1984
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · CFL
Nichols Institute Diagnostics
Chemistry · 223d
Cleared Oct 22, 1984
TSH RECEPTOR ANTIBODY KIT 125I TSH
K841580 · JZO
Clinetics Corp.
Chemistry · 188d
Cleared Oct 22, 1984
SALICYLATE ASSAY KIT
K842158 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 145d
Cleared Oct 17, 1984
ANALOX LM3 MICRO-STAT ANALYSER
K843082 · JJE
Analox Instruments , Ltd.
Chemistry · 72d