Cleared Traditional

QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

K942222 · Isolab, Inc. · Hematology
Jan 1995
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K942222 is an FDA 510(k) clearance for the QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS, a Control, Hemoglobin, Abnormal (Class II — Special Controls, product code JCM), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 20, 1995, 259 days after receiving the submission on May 6, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K942222 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1994
Decision Date January 20, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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

Similar Devices — JCM Control, Hemoglobin, Abnormal

All 11
EXTENDSURE HBFASC CONTROL
K053031 · Cantebury Scientific , Ltd. · Dec 2005
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
K011389 · Canterbury Health Laboratories · Jun 2001
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · Roche Diagnostic Systems, Inc. · Feb 1999
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · Helena Laboratories · Oct 1994
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · Isolab, Inc. · May 1993
HEMOCARD(TM) CONTROL
K924173 · Isolab, Inc. · Dec 1992