Cleared Traditional

PLATELET AGGREGATION PROFILER #PAP-4

K821005 · Bio/Data Corp. · Hematology
Jun 1982
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K821005 is an FDA 510(k) clearance for the PLATELET AGGREGATION PROFILER #PAP-4, a Aggregrometer, Platelet (Class II — Special Controls, product code JBX), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982, 50 days after receiving the submission on April 12, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6675.

Submission Details

510(k) Number K821005 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1982
Decision Date June 01, 1982
Days to Decision 50 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