CMV IGM TEST— 510(k) K831711

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K831711 for CMV IGM TEST, Substantially Equivalent on 1983-10-27. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1983-05-27
Decision date: 1983-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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