Cleared Traditional

TRI-COUNT CALIBRATOR

K844708 · Hematology Marketing Assoc. · Hematology
Mar 1985
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K844708 is an FDA 510(k) clearance for the TRI-COUNT CALIBRATOR, a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on March 5, 1985, 92 days after receiving the submission on December 3, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K844708 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1984
Decision Date March 05, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSA — Calibrator For Red-cell And White-cell Counting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8185

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