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
433–456 of 673
Cleared Jul 19, 1990
BLOOD GAS/ISE CONTROLS
K902094
Phoenix Diagnostics, Inc.
Chemistry · 72d
Cleared Jul 19, 1990
BILIRUBIN CONTROL
K902616
Phoenix Diagnostics, Inc.
Chemistry · 36d
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 Jun 12, 1990
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
K902095
Phoenix Diagnostics, Inc.
Chemistry · 35d
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 19, 1990
CLP NORMAL LIPID CONTROL
K895862
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Jan 18, 1990
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3
K895905
Bio-Rad
Toxicology · 104d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-LR
K896246
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-HR
K896247
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 02, 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522
Casco Standards
Chemistry · 48d
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943
Sclavo, Inc.
Chemistry · 77d
Cleared Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078
Bio-Rad
Chemistry · 56d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252
Bio-Rad
Immunology · 42d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
K893141
Casco Standards
Chemistry · 59d