CHAGAS' IGG ELISA TEST— 510(k) K911233

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K911233 for CHAGAS' IGG ELISA TEST, Substantially Equivalent on 1992-05-04. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code MIU
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 1991-03-20
Decision date: 1992-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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