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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12673–12696 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 1978
SPECTROPHOTOMETERS
K780342 · JXR
The Perkin-Elmer Corp.
Chemistry · 39d
Cleared Apr 06, 1978
NEPHELOMETER
K780251 · JQX
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Apr 06, 1978
CHOLESTEROL RAPID SLAT KIT HDL
K780331 · CHH
Pierce Chemical Co.
Chemistry · 37d
Cleared Apr 05, 1978
DIRECT UREA NITROGEN TEST
K780262 · CDW
Hycel, Inc.
Chemistry · 47d
Cleared Apr 05, 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Apr 05, 1978
DIAGNOSTIC KIT, CPK
K780311 · CGS
Sclavo, Inc.
Chemistry · 40d
Cleared Apr 04, 1978
PREGNANCY TEST KIT, OVER-THE-COUNTER
K780321 · LCX
Intl. Diagnostic, Inc.
Chemistry · 39d
Cleared Mar 30, 1978
AUTO ISO-FILTER COLLECTION TUBE CAP
K780303 · GJE
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Mar 30, 1978
ROCHE TSH RIA
K780428 · JLW
Hoffmann-La Roche, Inc.
Chemistry · 13d
Cleared Mar 28, 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Mar 28, 1978
HDL CHOLESTEROL METHOD
K780256 · JHO
Helena Laboratories
Chemistry · 43d
Cleared Mar 27, 1978
SPECTROPHOTOMETER, FLUORESCENCE M.650-10
K780242 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 17, 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · CDX
Syva Co.
Chemistry · 53d
Cleared Mar 09, 1978
ANALYZER, SELECTIVE, ELECTRONIC
K780083 · JJE
Johns Scientific, Inc.
Chemistry · 52d
Cleared Mar 09, 1978
ULTRAZYME PLUS GT
K780099 · JPZ
Harleco
Chemistry · 48d
Cleared Mar 09, 1978
ULTRAZYME PLUS CK-1
K780100 · CGS
Harleco
Chemistry · 48d
Cleared Mar 09, 1978
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
K780141 · CIJ
Harleco
Chemistry · 42d
Cleared Mar 09, 1978
TRIGLYCERIDE INSTRUMENT APPLICATION
K780172 · CDT
Harleco
Chemistry · 35d
Cleared Mar 03, 1978
AUTOZYME GLUCOSE OXIDASE (TRINDER)
K772308 · CGA
J.T. Baker Chemical Co.
Chemistry · 77d
Cleared Mar 03, 1978
LDH ISOENZYME CONTROL SERUM
K780096 · JJY
Worthington Biochemical Corp.
Chemistry · 44d
Cleared Mar 03, 1978
CSF TOTAL PROTEIN TEST SET #0340
K780110 · JGQ
Stanbio Laboratory
Chemistry · 43d
Cleared Mar 03, 1978
RIA FOR FOLATES & VIT. B12, COMBO KIT
K780148 · CGN
Ria Products, Inc.
Chemistry · 32d
Cleared Mar 03, 1978
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204 · JJT
Hyland Therapeutic Div., Travenol...
Chemistry · 24d
Cleared Mar 03, 1978
ASPIRATOR, MANUEL
K780208 · JQW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 24d