JJX · Class I · 21 CFR 862.1660

FDA Product Code JJX: Single (specified) Analyte Controls (assayed And Unassayed)

Leading manufacturers include Roche Diagnostics, Siemens Healthcare Diagnostics, Inc. and Boehringer Mannheim Corp..

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
433–456 of 493
Cleared Oct 11, 1979
SERACON -LO DO26
K791957
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Aug 10, 1979
BILIRUBIN CALIBRATOR CONTROL
K791141
Beckman Instruments, Inc.
Chemistry · 53d
Cleared Jul 17, 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jul 17, 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Apr 04, 1979
DUPONT ACA CKMB VERIFIERS
K790376
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 40d
Cleared Mar 21, 1979
SERUM PAK, HCG CONTROL
K790129
Mallinckrodt Critical Care
Chemistry · 57d
Cleared Feb 15, 1979
SERACON-LP
K782170
Bhp Diagnostix, Inc.
Chemistry · 48d
Cleared Feb 08, 1979
SERACON-HDL
K782171
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Jan 06, 1978
ACA LIPASE VERIFIERS
K772285
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 24d
Cleared Oct 28, 1977
ACA BILIRUBIN CALIBRATOR
K771798
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Oct 13, 1977
EMIT THYROXINE CONTROL
K771657
Syva Co.
Chemistry · 45d
Cleared Nov 05, 1976
KETOTROL-E
K760885
Sigma Chemical Co.
Chemistry · 14d
Cleared Oct 29, 1976
LIPID CONTROL
K760449
Sigma Chemical Co.
Chemistry · 74d