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
457–480 of 673
Cleared Jun 23, 1989
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
K893142
Casco Standards
Chemistry · 59d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680
Bio-Rad
Immunology · 84d
Cleared May 09, 1989
MONI-TROL(R)
K891929
Baxter Healthcare Corp
Immunology · 42d
Cleared Mar 20, 1989
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708
Amersham Corp.
Chemistry · 48d
Cleared Mar 15, 1989
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414
Amersham Corp.
Chemistry · 50d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 43d
Cleared Nov 10, 1988
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K883942
Icl Scientific
Toxicology · 52d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486
Bio-Rad
Chemistry · 131d
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861
Casco Standards
Chemistry · 30d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736
Amersham Corp.
Chemistry · 102d
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728
Amersham Corp.
Chemistry · 97d
Cleared Oct 06, 1988
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
K883147
Utak Laboratories, Inc.
Toxicology · 72d
Cleared Sep 30, 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124
Amersham Corp.
Chemistry · 66d
Cleared Aug 08, 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727
Amersham Corp.
Chemistry · 38d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542
Bio-Rad
Chemistry · 30d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 01, 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436
Hichem Diagnostics
Chemistry · 58d
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