INCSTAR HSZ I/II IGG ELISA ASSAY— 510(k) K955363

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K955363 for INCSTAR HSZ I/II IGG 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

Download summary PDF View on FDA.gov ↗

Recent devices under product code IGC

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K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY1996-10-24
K960367 — INCSTAR RUBELLA IGG ELISA ASSAY1996-10-24

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