JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
265–288 of 673
Cleared Mar 04, 1998
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
K980514
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904
Casco Standards
Microbiology · 198d
Cleared Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
K980178
Bionostics, Inc.
Chemistry · 23d
Cleared Jan 27, 1998
VIROTROL III
K974613
Blackhawk Biosystems, Inc.
Microbiology · 47d
Cleared Jan 22, 1998
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
K974822
Avl Scientific Corp.
Chemistry · 29d
Cleared Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
K974826
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE
K974827
Biosite Incorporated
Chemistry · 15d
Cleared Dec 17, 1997
VIGIL LIPID CONTROL
K974452
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Dec 08, 1997
ELECSYS CALCHECK FOLATE
K974384
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Oct 29, 1997
IMMUSURE
K973894
Quantimetrix Corp.
Chemistry · 15d
Cleared Oct 14, 1997
ABC LINEARITY VERIFIERS
K973790
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 14, 1997
ABC CALIBRATION VERIFIERS
K973791
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 07, 1997
PRECINORM RF, PRECIPATH RF
K973629
Boehringer Mannheim Corp.
Immunology · 13d
Cleared Sep 25, 1997
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
K973469
Consolidated Technologies, Inc.
Chemistry · 21d
Cleared Sep 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 8d
Cleared Sep 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
K973030
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
K972868
Bionostics, Inc.
Chemistry · 24d
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657
Boston Biomedica, Inc.
Microbiology · 98d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048
Boston Biomedica, Inc.
Microbiology · 71d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235
Boehringer Mannheim Corp.
Immunology · 57d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406
Boston Biomedica, Inc.
Microbiology · 113d
Cleared Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307
Boston Biomedica, Inc.
Microbiology · 49d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608
Randox Laboratories, Ltd.
Immunology · 54d
Cleared Jun 26, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
K972070
Nichols Institute Diagnostics
Chemistry · 23d