Cleared Traditional

K962571 - COAGUCHEK PST SYSTEM (FDA 510(k) Clearance)

K962571 · Boehringer Mannheim Corp. · Hematology device

Apr 1997

Decision

295d

Days

Class 2

Risk

K962571 is an FDA 510(k) clearance for the COAGUCHEK PST SYSTEM. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 22, 1997, 295 days after receiving the submission on July 1, 1996.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K962571 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 01, 1996
Decision Date	April 22, 1997
Days to Decision	295 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF