FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11161–11184 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 05, 1982
IMMU-COUNT
K820137 · JJJ
Kemble Instruments, Inc.
Chemistry · 18d
Cleared Feb 04, 1982
FSH RADIOIMMUNOASSAY TEST SYSTEM
K820048 · CGJ
Monobind
Chemistry · 27d
Cleared Feb 04, 1982
ELECTROLYTE ANALYZER ACCESSORY
K820118 · JJE
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Jan 29, 1982
ALKALINE PHOSPHATASE REAGENT SET
K812837 · CJL
Anco Medical Reagents & Assoc.
Chemistry · 112d
Cleared Jan 29, 1982
LIQUIZYME CREATININE REAGENT SET
K813560 · CGX
Amresco, Inc.
Chemistry · 38d
Cleared Jan 28, 1982
MINIWASH II
K813640 · LIB
Dynatech Corp.
Chemistry · 28d
Cleared Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
K820043 · LIB
American Dade
Chemistry · 21d
Cleared Jan 28, 1982
CORTISOL (RIA) KIT
K820074 · CGR
Immuno Assay Corp.
Chemistry · 16d
Cleared Jan 28, 1982
TSH (RIA) KIT
K820089 · JLW
Immuno Assay Corp.
Chemistry · 15d
Cleared Jan 28, 1982
ASTRA-T CALCIUM REAGENT
K820090 · CIC
Hi Chem, Inc.
Chemistry · 15d
Cleared Jan 28, 1982
PATHWAY PH BLOOD GAS CONTROL
K820103 · JJS
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Jan 28, 1982
PRIMIDONE REAGENT TEST KIT
K820138 · DJD
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Jan 26, 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · CGX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 22, 1982
SODIUM & POTASSIUM PRODUCTS
K813127 · JIX
Alko Diagnostic Corp.
Chemistry · 78d
Cleared Jan 22, 1982
TDX PRIMIDONE
K813597 · DJD
Abbott Laboratories
Chemistry · 25d
Cleared Jan 22, 1982
POTASSIUM REAGENT SET
K813608 · CEJ
Diagnostic Specialties
Chemistry · 24d
Cleared Jan 22, 1982
MICROMEDIC HTSH RIA KIT
K813645 · JLW
Micromedic Systems
Chemistry · 22d
Cleared Jan 22, 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · CFT
Leeco Diagnostics, Inc.
Chemistry · 15d
Cleared Jan 19, 1982
ABBOTT PAP-EIA
K812925 · JFH
Abbott Laboratories
Chemistry · 92d
Cleared Jan 18, 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · CGI
Diagnostic Products Corp.
Chemistry · 105d
Cleared Jan 18, 1982
GLUCOSE ENZYME-COLOR REAGENT SET
K813555 · CGA
Biorent Diagnostic, Inc.
Chemistry · 27d
Cleared Jan 18, 1982
CARDIOTRAC CORNING CK ISOENZYME SUBST
K813573 · JHX
Corning Medical & Scientific
Chemistry · 27d
Cleared Jan 18, 1982
Q-LINE LTC
K813580 · JJY
Miles Laboratories, Inc.
Chemistry · 25d
Cleared Dec 31, 1981
GLUCOSE ENZYME-COLOR REAGENT SET
K813412 · CGA
Diagnostic Specialties
Chemistry · 27d