EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA— 510(k) K921628

Name: FDA 510(k) clearance K921628
Creator: U.S. Food and Drug Administration
Published: 1992-09-14

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K921628 for EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA, Substantially Equivalent on 1992-09-14. Applicant: Incstar Corp.. Device class: 1.

Clearance details

Applicant: Incstar Corp.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1992-04-06
Decision date: 1992-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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