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
9625–9648 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 10, 1984
COAT-A-COUNT ANDROSTENEDIONE RIA KIT
K844398 · CIZ
Diagnostic Products Corp.
Chemistry · 27d
Cleared Dec 10, 1984
SANDARE ALKALINE PHOSPHATASE PROCEDURE
K844498 · CIO
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Nov 30, 1984
RESOLVE-CSF
K843122 · DFI
Isolab, Inc.
Chemistry · 114d
Cleared Nov 27, 1984
ENZYME IMMUNOASSAY FOR DETECTION HORM
K841545 · CEP
Btc Diagnostics, Inc.
Chemistry · 225d
Cleared Nov 27, 1984
ULTRA LYTE SODIUM REAGENT KIT
K843453 · JGS
Ultra Quest Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 27, 1984
ULTRA LYTE POTASSIUM REAGENT KIT
K843454 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 27, 1984
TRIGLYCERIDES REAGENT SYSTEM
K843832 · CDT
Fermco Biochemics, Inc.
Chemistry · 57d
Cleared Nov 27, 1984
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3
K843986 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3
K844018 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
SERACON TM SR IV
K844026 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
SERACON TM SR III
K844027 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · CEM
Medica Corp.
Chemistry · 41d
Cleared Nov 27, 1984
ENI BLOOD UREA NITROGEN REAGENT
K844065 · CDQ
Electro-Nucleonics Laboratories, Inc.
Chemistry · 40d
Cleared Nov 27, 1984
TDX SALICYLATE
K844070 · DKJ
Abbott Laboratories
Chemistry · 40d
Cleared Nov 27, 1984
ADD-1
K844114 · JJE
Abbott Laboratories
Chemistry · 35d
Cleared Nov 27, 1984
ACTH RIA
K844181 · CKG
Syncor Intl. Corp.
Chemistry · 32d
Cleared Nov 27, 1984
SGPT REAGENT SET
K844283 · CKD
Livonia Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 27, 1984
SGOT REAGENT SET
K844322 · CIQ
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 20, 1984
AMYLASE REAGENT CS-726
K844168 · CJA
Fisher Scientific Co., LLC
Chemistry · 26d
Cleared Nov 20, 1984
CHLORIDE STANDARD
K844235 · JIS
Shaban Mfg. Co.
Chemistry · 19d
Cleared Nov 20, 1984
ALKALINE PHOSPHATASE REAGENT SET
K844237 · CIO
Livonia Diagnostics, Inc.
Chemistry · 19d
Cleared Nov 13, 1984
TANDEM - EPRL
K843804 · CFT
Hybritech, Inc.
Chemistry · 47d
Cleared Nov 13, 1984
UREA NITROGEN REAGENT SET
K844156 · CDW
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
K842669 · CFE
Helena Laboratories
Chemistry · 122d