ABS CADKIT— 510(k) K910636

Substantially Equivalent

Panbio, Inc.

FDA 510(k) clearance K910636 for ABS CADKIT, Substantially Equivalent on 1991-04-29. Applicant: Panbio, Inc.. Device class: 2.

Clearance details

Applicant: Panbio, Inc.
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1991-02-13
Decision date: 1991-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, 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.