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
385–408 of 673
Cleared Sep 02, 1992
MONI-TROL-L AND MONI-TROL-XL
K920291
Medical Analysis Systems, Inc.
Chemistry · 224d
Cleared Aug 10, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165
Eastman Kodak Company
Chemistry · 42d
Cleared Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046
Bio-Rad
Chemistry · 70d
Cleared Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636
Baxter Diagnostics, Inc.
Chemistry · 146d
Cleared Jun 19, 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927
Helena Laboratories
Chemistry · 112d
Cleared Jun 09, 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286
Bio-Rad
Chemistry · 84d
Cleared May 07, 1992
KEMTROL SERUM CONTROL-ABNORMAL
K920926
Helena Laboratories
Chemistry · 69d
Cleared Apr 17, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K920940
Eastman Kodak Company
Chemistry · 50d
Cleared Apr 07, 1992
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
K920826
Eastman Kodak Company
Chemistry · 43d
Cleared Mar 23, 1992
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
K920350
Streck Laboratories, Inc.
Chemistry · 59d
Cleared Mar 17, 1992
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3
K914204
Medical Analysis Systems, Inc.
Chemistry · 180d
Cleared Feb 06, 1992
N/T PROTEIN CONTROL UY
K914890
Behring Diagnostics, Inc.
Chemistry · 98d
Cleared Jan 09, 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
K914255
Bio-Rad
Chemistry · 108d
Cleared Dec 18, 1991
RAI-TROL ELEVATED LIPIDS CONTROL
K915191
Reagents Applications, Inc.
Chemistry · 29d
Cleared Nov 22, 1991
CVM
K914619
Ciba Corning Diagnostics Corp.
Chemistry · 37d
Cleared Sep 27, 1991
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
K913133
Bionostics, Inc.
Chemistry · 73d
Cleared Sep 25, 1991
LIPID LINEARITY CONTROLS
K913224
Creative Laboratory Products, Inc.
Chemistry · 68d
Cleared Sep 19, 1991
CHEM-CHEX
K913687
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Sep 06, 1991
ENZYME LINEARITY CONTROL
K912718
Phoenix Diagnostics, Inc.
Chemistry · 80d
Cleared Aug 12, 1991
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455
Baxter Healthcare Corp
Chemistry · 70d
Cleared Jul 30, 1991
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K912725
Creative Laboratory Products, Inc.
Chemistry · 40d
Cleared Jul 17, 1991
LINEARITY TEST KITS
K912441
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Jun 13, 1991
ANEMIA I, II
K911984
Ciba Corning Diagnostics Corp.
Hematology · 41d
Cleared Jun 10, 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854
Baxter Healthcare Corp
Chemistry · 45d