TPP— 510(k) K962176

Substantially Equivalent

Panbio, Inc.

FDA 510(k) clearance K962176 for TPP, Substantially Equivalent on 1996-10-18. Applicant: Panbio, Inc.. Device class: 2.

Clearance details

Applicant: Panbio, Inc.
Product code: Code MIF
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1996-06-05
Decision date: 1996-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, 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.