GULL ELISAWARE— 510(k) K912558

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K912558 for GULL ELISAWARE, Substantially Equivalent on 1991-09-16. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LIB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-06-11
Decision date: 1991-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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