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
313–336 of 673
Cleared Dec 06, 1990
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL
K904829
Analytical Control Systems, Inc.
Chemistry · 42d
Cleared Dec 06, 1990
QCLYTE PROTEIN BASED ISE CONTROL
K904968
Baxter Healthcare Corp
Chemistry · 31d
Cleared Nov 09, 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768
Eastman Kodak Company
Chemistry · 18d
Cleared Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 12, 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293
Hichem Diagnostics
Chemistry · 23d
Cleared Oct 04, 1990
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933
Baxter Healthcare Corp
Chemistry · 38d
Cleared Sep 24, 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566
Baxter Healthcare Corp
Immunology · 48d
Cleared Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
K903310
Medical Analysis Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 38d
Cleared Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
K903190
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
K903225
Medical Analysis Systems, Inc.
Chemistry · 25d
Cleared Jul 17, 1990
LVM QUALITY CONTROL SERUM
K902235
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Jul 17, 1990
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
K902673
Hi Chem, Inc.
Chemistry · 29d
Cleared Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared May 31, 1990
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
K901988
Casco Standards
Chemistry · 29d
Cleared May 01, 1990
LIG/TDM A, B, C
K901212
Ciba Corning Diagnostics Corp.
Chemistry · 48d
Cleared Apr 26, 1990
TECHNICON TESTPOINT(TM) LIGAND CONTROL
K900717
Technicon Instruments Corp.
Chemistry · 71d
Cleared Apr 19, 1990
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115
Hichem Diagnostics
Chemistry · 41d
Cleared Apr 16, 1990
CHEM-CHEX
K900993
Streck Laboratories, Inc.
Chemistry · 45d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642
Baxter Healthcare Corp
Toxicology · 296d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905
Bio-Rad
Toxicology · 104d
Cleared Jan 02, 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522
Casco Standards
Chemistry · 48d