Cleared Traditional

HEMOTOLOGY CALIBRATOR

K813530 · American Dade · Hematology
Feb 1982
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K813530 is an FDA 510(k) clearance for the HEMOTOLOGY CALIBRATOR, a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by American Dade (Walker, US). The FDA issued a Cleared decision on February 22, 1982, 67 days after receiving the submission on December 17, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K813530 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1981
Decision Date February 22, 1982
Days to Decision 67 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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