FIF TM— 510(k) K970189

Substantially Equivalent

Panbio, Inc.

FDA 510(k) clearance K970189 for FIF TM, Substantially Equivalent on 1997-05-21. Applicant: Panbio, Inc.. Device class: 2.

Clearance details

Applicant: Panbio, Inc.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1997-01-21
Decision date: 1997-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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K962176 — TPP1996-10-18
K910636 — ABS CADKIT1991-04-29

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