Cleared Traditional

HEMOCARD(TM) CONTROL

K924173 · Isolab, Inc. · Hematology
Dec 1992
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K924173 is an FDA 510(k) clearance for the HEMOCARD(TM) CONTROL, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on December 1, 1992, 104 days after receiving the submission on August 19, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K924173 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1992
Decision Date December 01, 1992
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCM — Control, Hemoglobin, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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