INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY— 510(k) K955361

Name: FDA 510(k) clearance K955361
Creator: U.S. Food and Drug Administration
Published: 1996-07-22

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K955361 for INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY, Substantially Equivalent on 1996-07-22. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1995-11-22
Decision date: 1996-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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