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 Cala Diagnostics.

97
Total
97
Cleared
45d
Avg days
1977
Since
97 devices
73–96 of 97
Cleared May 14, 1982
TARGET ISOCHECK CONTROL SERUM
K821183
Smithkline Diagnostics, Inc.
Chemistry · 17d
Cleared Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
K820360
Aalto Scientific, Ltd.
Chemistry · 23d
Cleared Oct 02, 1981
EMBRITROL CK-MB CONTROLS
K812671
Intl. Immunoassay Laboratories, Inc.
Chemistry · 11d
Cleared Apr 14, 1981
GEMENI CK-MB ISOENZYME ABNORMAL SERUM
K810870
Gemini, Inc.
Chemistry · 14d
Cleared Mar 31, 1981
QUALITROL #65057
K810725
Harleco
Immunology · 14d
Cleared Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d
Cleared Apr 10, 1980
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Oct 01, 1979
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723
Organon, Inc.
Chemistry · 32d
Cleared Aug 16, 1979
CPK ISOENZYME CONTROL
K791299
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
LDH ISOENZYME CONTROL
K791300
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Jul 17, 1979
P.A.P. RIA CONTROL SERUM PACK
K790985
Mallinckrodt Critical Care
Chemistry · 53d
Cleared Aug 14, 1978
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 42d
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 Sep 02, 1977
SERONORM
K771436
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
AUTONORM
K771438
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
PATHONORM H & L
K771439
Nyegaard & Co. A/S
Chemistry · 32d
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 Jun 03, 1977
CPK ISOENZYME CONTROL
K770555
Bio-Reagents & Diagnostics, Inc.
Chemistry · 74d