LYME IGM ELISA TEST— 510(k) K903013

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K903013 for LYME IGM ELISA TEST, Substantially Equivalent on 1991-06-21. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-07-11
Decision date: 1991-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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