AIA-PACK CA 125— 510(k) K990431

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K990431 for AIA-PACK CA 125, Substantially Equivalent on 1999-06-03. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-02-11
Decision date: 1999-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, 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.