Cleared Traditional

FIF TM

K970189 · Panbio, Inc. · Hematology
May 1997
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K970189 is an FDA 510(k) clearance for the FIF TM, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Panbio, Inc. (South Bend, US). The FDA issued a Cleared decision on May 21, 1997, 120 days after receiving the submission on January 21, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K970189 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1997
Decision Date May 21, 1997
Days to Decision 120 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQJ — System, Fibrinogen Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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