EBV-EA TEST— 510(k) K872617

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K872617 for EBV-EA TEST, Substantially Equivalent on 1988-01-05. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant
Gull Laboratories, Inc.
Product code
Code LSE
Device class
Class 1
Regulation
21 CFR 866.3235
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
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