JJT · Class I · 21 CFR 862.1660

FDA Product Code JJT: Enzyme Controls (assayed And Unassayed)

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

97
Total
97
Cleared
45d
Avg days
1977
Since
97 devices
73–96 of 97
Cleared Jun 13, 1978
ISOZYME - ID CPK MARKER
K780801
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 06, 1978
CLIN. CHEM. CONTROL SERUM-QUANTITATE
K780554
Beckman Instruments, Inc.
Chemistry · 62d
Cleared Mar 03, 1978
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 24d
Cleared Feb 23, 1978
ISOENZYME SERUM CONTROL
K780147
Corning Medical & Scientific
Chemistry · 24d
Cleared Oct 25, 1977
ACA GLUTAMYL TRANSFERASE
K771800
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 32d
Cleared Oct 19, 1977
CARDIOZYME CK-CONTROL LEVEL 1
K771740
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 34d
Cleared Aug 04, 1977
CARDIOZYME CK-CONTROL ABNORMAL
K770971
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
CARDIOZYME CK CONTROL NORMAL
K770973
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Jan 26, 1977
LDH ISOTROL T
K770049
Sigma Chemical Co.
Chemistry · 16d