JJX · Class I · 21 CFR 862.1660

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

Leading manufacturers include Boehringer Mannheim Corp., Roche Diagnostics Corp. and Bio-Rad.

493
Total
493
Cleared
62d
Avg days
1976
Since
493 devices
97–120 of 493
Cleared Oct 25, 1989
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528
Helena Laboratories
Chemistry · 49d
Cleared Aug 01, 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475
Bio-Rad
Chemistry · 138d
Cleared Mar 12, 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151
3M Company
Immunology · 58d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126
Abbott Laboratories
Chemistry · 31d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Apr 10, 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772
Helena Laboratories
Chemistry · 50d
Cleared Jul 23, 1981
HELENA VMA-SMC CONTROL
K811912
Helena Laboratories
Chemistry · 22d
Cleared Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068
Beckman Instruments, Inc.
Chemistry · 44d
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 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