DAC-CEL HCG-MCA KIT RD52— 510(k) K831073

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K831073 for DAC-CEL HCG-MCA KIT RD52, Substantially Equivalent on 1983-09-01. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1983-04-04
Decision date: 1983-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.