Cleared Traditional

HEMOCARD HEMOGLOBIN S

K911981 · Isolab, Inc. · Hematology
Oct 1991
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K911981 is an FDA 510(k) clearance for the HEMOCARD HEMOGLOBIN S, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on October 9, 1991, 159 days after receiving the submission on May 3, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K911981 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1991
Decision Date October 09, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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