Cleared Traditional

HEMOCARD-AS

K910430 · Isolab, Inc. · Hematology
Apr 1991
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K910430 is an FDA 510(k) clearance for the HEMOCARD-AS, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on April 15, 1991, 73 days after receiving the submission on February 1, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K910430 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1991
Decision Date April 15, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHM — Test, Sickle Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7825