RSV-MAB TEST— 510(k) K912842

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K912842 for RSV-MAB TEST, Substantially Equivalent on 1991-12-09. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1991-06-26
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.