DETECTADOT SYSTEM 2000 CMV IGG TEST— 510(k) K875159

Name: FDA 510(k) clearance K875159
Creator: U.S. Food and Drug Administration
Published: 1988-05-06

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K875159 for DETECTADOT SYSTEM 2000 CMV IGG TEST, Substantially Equivalent on 1988-05-06. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1987-12-16
Decision date: 1988-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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