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
361–384 of 493
Cleared Nov 05, 1992
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
K923794
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
K923821
Casco Standards
Chemistry · 98d
Cleared Aug 12, 1992
LIPID CONTROLS
K922995
Creative Laboratory Products, Inc.
Chemistry · 51d
Cleared Jul 30, 1992
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
K922904
Reagents Applications, Inc.
Chemistry · 44d
Cleared Jul 17, 1992
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556
Hybritech, Inc.
Chemistry · 162d
Cleared Jul 17, 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252
Hybritech, Inc.
Chemistry · 123d
Cleared Apr 29, 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089
Bio-Rad
Chemistry · 54d
Cleared Apr 29, 1992
HCG CONTROL
K921206
Polymedco, Inc.
Chemistry · 47d
Cleared Mar 02, 1992
TSH CONTROL
K915325
Polymedco, Inc.
Chemistry · 101d
Cleared Jan 30, 1992
MILENIA DATA REDUCTION
K915806
Diagnostic Products Corp.
Chemistry · 37d
Cleared Oct 21, 1991
LIPASE LINEARITY CONTROL
K913585
Creative Laboratory Products, Inc.
Chemistry · 70d
Cleared Sep 25, 1991
QUANTIMETRIX AMMONIA CONTROLS
K913346
Quantimetrix Corp.
Chemistry · 61d
Cleared Sep 25, 1991
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
K913792
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 11, 1991
CHOLINESTERASE LINEARITY CONTROL
K913496
Creative Laboratory Products, Inc.
Chemistry · 36d
Cleared Aug 28, 1991
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439
Hybritech, Inc.
Chemistry · 86d
Cleared May 31, 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664
Quidel Corp.
Chemistry · 49d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
K911177
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared Feb 04, 1991
BIOTROL BILIRUBIN C & T CONTROL
K905280
Biotrol, USA, Inc.
Chemistry · 73d
Cleared Nov 02, 1990
SERACON CR REFERENCE
K904503
Bhp Diagnostix, Inc.
Chemistry · 31d
Cleared Oct 15, 1990
DUPONT DRUG CALIBRATOR-A
K904306
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
K902569
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
CHEM-CHEX-ALT
K903147
Streck Laboratories, Inc.
Chemistry · 22d