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
193–216 of 493
Cleared Aug 20, 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122
Maine Standards Co.
Chemistry · 45d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Apr 11, 2001
VIGIL DNASE B CONTROL
K010693
Beckman Coulter, Inc.
Immunology · 34d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967
Roche Diagnostics Corp.
Immunology · 21d
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112
Ortho-Clinical Diagnostics, Inc.
Microbiology · 29d
Cleared Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
K002540
Bionostics, Inc.
Chemistry · 33d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443
Streck Laboratories, Inc.
Chemistry · 52d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846
Roche Diagnostics Corp.
Chemistry · 9d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
K001014
Roche Diagnostics Corp.
Immunology · 64d
Cleared Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015
Roche Diagnostics Corp.
Immunology · 29d
Cleared Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781
Bio-Rad
Immunology · 230d
Cleared Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042
Roche Diagnostics Corp.
Chemistry · 71d
Cleared Mar 02, 2000
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
K000231
Biosite Incorporated
Chemistry · 35d
Cleared Feb 29, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
K000230
Biosite Incorporated
Chemistry · 33d
Cleared Feb 28, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000318
Bionostics, Inc.
Chemistry · 27d
Cleared Jan 18, 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
K994200
Beckman Coulter, Inc.
Immunology · 36d
Cleared Jan 14, 2000
ACCESS OSTASE QC
K994277
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
K993210
Beckman Coulter, Inc.
Immunology · 103d
Cleared Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
K993642
Roche Diagnostics Corp.
Immunology · 33d