PROGENE(TM) IGE TEST— 510(k) K875125

Substantially Equivalent

Progene Corp.

FDA 510(k) clearance K875125 for PROGENE(TM) IGE TEST, Substantially Equivalent on 1988-02-25. Applicant: Progene Corp.. Device class: 2.

Clearance details

Applicant: Progene Corp.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1987-12-15
Decision date: 1988-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

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More clearances from Progene Corp.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.