JIX · Class II · 21 CFR 862.1150

FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Leading manufacturers include Alko Diagnostic Corp., Dade Behring, Inc. and Bhp Diagnostix, Inc..

302
Total
302
Cleared
66d
Avg days
1976
Since
302 devices
265–288 of 302
Cleared Feb 08, 1979
SERACON-A
K782037
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Dec 04, 1978
SERACON-SRI
K781757
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
SERACON-SRII
K781758
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared May 19, 1978
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Apr 18, 1977
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A
K770010
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 105d
Cleared Apr 18, 1977
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B
K770011
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 105d
Cleared Apr 18, 1977
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C
K770012
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 105d
Cleared Feb 11, 1977
SMA REFERENCE SERUM 3
K770142
Technicon Instruments Corp.
Chemistry · 18d
Cleared Dec 30, 1976
OB-GYN CONTROL SERA (CODE 196300)
K761309
Amersham Corp.
Immunology · 7d