Cleared Traditional

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS

K864664 · Technicon Instruments Corp. · Hematology
Feb 1987
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K864664 is an FDA 510(k) clearance for the H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS, a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on February 6, 1987, 70 days after receiving the submission on November 28, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K864664 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1986
Decision Date February 06, 1987
Days to Decision 70 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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