EBV-CHECK(TM) TEST KIT (IGG)— 510(k) K871373

Name: FDA 510(k) clearance K871373
Creator: U.S. Food and Drug Administration
Published: 1987-06-25

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K871373 for EBV-CHECK(TM) TEST KIT (IGG), Substantially Equivalent on 1987-06-25. Applicant: Diagnostic Technology, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1987-04-07
Decision date: 1987-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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