INCSTAR HSV I/II IGG FAST ELISA ASSAY— 510(k) K955362

Name: FDA 510(k) clearance K955362
Creator: U.S. Food and Drug Administration
Published: 1996-07-24

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K955362 for INCSTAR HSV I/II IGG FAST ELISA ASSAY, Substantially Equivalent on 1996-07-24. Applicant: Incstar Corp.. Device class: 1.

Clearance details

Applicant: Incstar Corp.
Product code: Code IGC
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1995-11-22
Decision date: 1996-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY1996-07-24

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