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
9769–9792 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 04, 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · CEM
American Monitor Corp.
Chemistry · 35d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT DIRECT
K843027 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
K843110 · JIS
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 29, 1984
TDX DISOPYRAMIDE
K842713 · LBZ
Abbott Laboratories
Chemistry · 48d
Cleared Aug 29, 1984
ALLERGENTICS TOTAL IGE/THEOPHYLLINE
K842970 · JJY
Allergenetics
Chemistry · 30d
Cleared Aug 29, 1984
UNIVERSAL 2 S CENTRIFUGE
K843087 · JQC
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Aug 29, 1984
EBA 3 S CENTRIFUGE
K843088 · JQC
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Aug 29, 1984
SYSTEMATE CALCIUM 67214
K843152 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 19d
Cleared Aug 28, 1984
ALLERGENETICS ALLER-SPECIFIC IGE SERUM
K842969 · DGP
Allergenetics
Chemistry · 29d
Cleared Aug 27, 1984
KEMBLE 405
K842894 · JQW
Kemble Instruments, Inc.
Chemistry · 35d
Cleared Aug 27, 1984
TOTAL PROTEIN ASSAY KIT
K843028 · CEK
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · LBS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
INORGANIC PHOSPHORUS ASSAY KIT
K843030 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
MAGNESIUM ASSAY KIT
K843031 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 27, 1984
UREA ASSAY KIT
K843057 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Aug 27, 1984
SYSTEMATE CREATININE 67223
K843105 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67216
K843150 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151 · CGA
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 24, 1984
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · KQO
Miles Laboratories, Inc.
Chemistry · 165d
Cleared Aug 24, 1984
DUOCLON COLOR-CEPT
K842314 · JHJ
Organon, Inc.
Chemistry · 73d