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
289–312 of 493
Cleared Jan 28, 1993
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
K925479
Streck Laboratories, Inc.
Chemistry · 147d
Cleared Jan 26, 1993
REFRACTROL-SP
K926095
Medical Specialties, Inc.
Chemistry · 55d
Cleared Jan 11, 1993
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493
Casco Standards
Chemistry · 136d
Cleared Jan 11, 1993
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
K924852
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 11, 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
K924856
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Dec 28, 1992
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
K924853
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 28, 1992
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
K924862
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Nov 16, 1992
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
K924854
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
K924855
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 16, 1992
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
K924863
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Nov 05, 1992
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
K923793
Casco Standards
Chemistry · 100d
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 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 Jan 30, 1992
MILENIA DATA REDUCTION
K915806
Diagnostic Products Corp.
Chemistry · 37d
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 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