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
25–48 of 493
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772
Roche Diagnostics Corp.
Chemistry · 14d
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 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
Cleared Mar 30, 1999
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
K990608
Bio-Rad
Chemistry · 34d
Cleared Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
K990393
Bio-Rad
Chemistry · 41d
Cleared Feb 02, 1999
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
K984604
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
K984625
Bio-Rad
Chemistry · 36d
Cleared Jan 29, 1999
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
K984626
Bio-Rad
Chemistry · 32d
Cleared Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162
Bio-Rad
Chemistry · 9d
Cleared Dec 22, 1998
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
K984319
Bio-Rad
Chemistry · 19d
Cleared Dec 22, 1998
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
K984327
Bio-Rad
Chemistry · 19d
Cleared Dec 15, 1998
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
K984318
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
K984323
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
K984324
Bio-Rad
Chemistry · 12d
Cleared Dec 03, 1998
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
K984071
Bio-Rad
Chemistry · 17d
Cleared Nov 25, 1998
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
K984070
Bio-Rad
Chemistry · 9d