Cleared Traditional

TPP

K962176 · Panbio, Inc. · Hematology
Oct 1996
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K962176 is an FDA 510(k) clearance for the TPP, a Prothrombin Fragment 1.2 (Class II — Special Controls, product code MIF), submitted by Panbio, Inc. (South Bend, US). The FDA issued a Cleared decision on October 18, 1996, 135 days after receiving the submission on June 5, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K962176 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1996
Decision Date October 18, 1996
Days to Decision 135 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code MIF — Prothrombin Fragment 1.2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320