INCSTAR'S BIRCH ALLERGEN DISC— 510(k) K880168

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K880168 for INCSTAR'S BIRCH ALLERGEN DISC, Substantially Equivalent on 1988-05-11. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1988-01-15
Decision date: 1988-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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