Cleared Traditional

TRI-COUNT

K851375 · Hematology Marketing Assoc. · Hematology
Jul 1985
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K851375 is an FDA 510(k) clearance for the TRI-COUNT, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on July 12, 1985, 95 days after receiving the submission on April 8, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K851375 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1985
Decision Date July 12, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625