AIA-PACK HGH— 510(k) K905757

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K905757 for AIA-PACK HGH, Substantially Equivalent on 1991-01-25. Applicant: Tosoh Medics, Inc.. Device class: 1.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1990-12-27
Decision date: 1991-01-25
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.