EBV-EA(D) IGG ELISA TEST— 510(k) K940093

Name: FDA 510(k) clearance K940093
Creator: U.S. Food and Drug Administration
Published: 1995-09-15

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K940093 for EBV-EA(D) IGG ELISA TEST, Substantially Equivalent on 1995-09-15. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1994-01-07
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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