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
361–384 of 673
Cleared May 27, 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447
Bionostics, Inc.
Chemistry · 115d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared May 16, 1988
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
K881275
Fisher Scientific Co., LLC
Chemistry · 52d
Cleared Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494
Bio-Rad
Chemistry · 28d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175
Baxter Healthcare Corp
Chemistry · 46d
Cleared Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731
Bio-Rad
Chemistry · 92d
Cleared Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280
Bio-Rad
Chemistry · 93d
Cleared Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 47d
Cleared Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Nov 23, 1987
PRECINORM L
K874230
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Jul 09, 1987
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
K871977
American Dade
Chemistry · 48d
Cleared Jul 06, 1987
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II
K872227
Bio-Rad
Chemistry · 27d
Cleared May 21, 1987
QM2/QM300 CONTROL A PACK
K871342
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared Apr 06, 1987
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
K871058
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Feb 20, 1987
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET
K870252
Casco Standards
Chemistry · 30d
Cleared Nov 24, 1986
MULTI-ANALYTE LIN-TROL
K863751
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Oct 07, 1986
ABNORMAL SPINAL FLUID CONTROL
K863745
Ciba Corning Diagnostics Corp.
Chemistry · 13d
Cleared Sep 16, 1986
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420
Quantimetrix Corp.
Chemistry · 154d
Cleared Sep 15, 1986
THERAPEUTIC DRUG MONITORING CONTROL SET
K862963
American Monitor Corp.
Chemistry · 40d
Cleared Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185
Bio-Rad
Chemistry · 56d
Cleared Jul 02, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999
Ciba Corning Diagnostics Corp.
Chemistry · 106d