Cleared Traditional

PAT PLATELET AGGREGATION TEST

K881829 · Streck Laboratories, Inc. · Hematology
Jul 1988
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K881829 is an FDA 510(k) clearance for the PAT PLATELET AGGREGATION TEST, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on July 1, 1988, 63 days after receiving the submission on April 29, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K881829 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1988
Decision Date July 01, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JBX — Aggregrometer, Platelet
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6675