Cleared Traditional

PLATELET AGGREGATION REAGENTS

K910286 · Medical Diagnostic Technologies, Inc. · Hematology
Mar 1991
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K910286 is an FDA 510(k) clearance for the PLATELET AGGREGATION REAGENTS, a Reagent, Platelet Aggregation (Class II — Special Controls, product code GHR), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on March 19, 1991, 56 days after receiving the submission on January 22, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K910286 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1991
Decision Date March 19, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHR — Reagent, Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700