JCM · Class II · 21 CFR 864.7415

FDA Product Code JCM: Control, Hemoglobin, Abnormal

Leading manufacturers include Isolab, Inc., Helena Laboratories and Bio-Rad.

12
Total
12
Cleared
115d
Avg days
1982
Since

FDA 510(k) Cleared Control, Hemoglobin, Abnormal Devices (Product Code JCM)

12 devices
1–12 of 12
Cleared Feb 10, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Jan 20, 1995
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222
Isolab, Inc.
Hematology · 259d
Cleared Oct 31, 1994
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086
Helena Laboratories
Hematology · 495d
Cleared May 11, 1993
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234
Isolab, Inc.
Chemistry · 62d
Cleared Dec 01, 1992
HEMOCARD(TM) CONTROL
K924173
Isolab, Inc.
Hematology · 104d
Cleared Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347
Bio-Rad
Hematology · 75d
Cleared Mar 11, 1991
HEMOCARD CONTROL
K910431
Isolab, Inc.
Hematology · 38d
Cleared Apr 08, 1982
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787
Helena Laboratories
Hematology · 16d

About Product Code JCM - Regulatory Context