GESTATE SLIDE EIKEN KIT AGG. METHOD HUM— 510(k) K802450

Name: FDA 510(k) clearance K802450
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K802450 for GESTATE SLIDE EIKEN KIT AGG. METHOD HUM, Substantially Equivalent on 1980-10-31. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1980-10-08
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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