AIA-PACK IRI— 510(k) K903628

Substantially Equivalent

Tosoh Corp.

FDA 510(k) clearance K903628 for AIA-PACK IRI, Substantially Equivalent on 1990-09-07. Applicant: Tosoh Corp.. Device class: 1.

Clearance details

Applicant: Tosoh Corp.
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1990-08-10
Decision date: 1990-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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