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
217–240 of 493
Cleared Nov 26, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
K981914
The Binding Site, Ltd.
Immunology · 543d
Cleared May 10, 1999
ATLAST GLUCOSE CONTROL SOLUTION
K991075
Amira Medical, Inc.
Chemistry · 40d
Cleared Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
K990984
Ortho-Clinical Diagnostics, Inc.
Immunology · 15d
Cleared Mar 30, 1999
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
K990608
Bio-Rad
Chemistry · 34d
Cleared Mar 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS
K990783
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
K990393
Bio-Rad
Chemistry · 41d
Cleared Mar 19, 1999
SAS HCG SERUM CONTROLS
K990720
Sa Scientific, Inc.
Chemistry · 14d
Cleared Mar 19, 1999
SAS HCG URINE CONTROLS
K990755
Sa Scientific, Inc.
Chemistry · 11d
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 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K990026
Ortho-Clinical Diagnostics, Inc.
Immunology · 24d
Cleared Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162
Bio-Rad
Chemistry · 9d
Cleared Jan 25, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
K990061
Ortho-Clinical Diagnostics, Inc.
Chemistry · 17d
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 17, 1998
SUPREME II CONTROL SOLUTIONS
K983432
Chronimed, Inc.
Chemistry · 79d
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 07, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
K984011
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
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
Cleared Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073
Bio-Rad
Chemistry · 9d