Cleared Traditional

ABS CADKIT

K910636 · Panbio, Inc. · Hematology
Apr 1991
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K910636 is an FDA 510(k) clearance for the ABS CADKIT, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Panbio, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 1991, 75 days after receiving the submission on February 13, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K910636 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1991
Decision Date April 29, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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