JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Roche Diagnostics Corp. and Boehringer Mannheim Corp..

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
145–168 of 673
Cleared Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
K860970
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Feb 06, 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125
Bio-Rad
Chemistry · 77d
Cleared Jul 06, 1984
KODAK EKTACHEM CONTROL
K841884
Eastman Kodak Company
Chemistry · 60d
Cleared Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
K833639
Helena Laboratories
Chemistry · 79d
Cleared Aug 16, 1982
TITAN GEL SERUM CONTROL
K821982
Helena Laboratories
Chemistry · 41d
Cleared May 21, 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Oct 19, 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
K811695
Helena Laboratories
Chemistry · 15d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109
Helena Laboratories
Chemistry · 37d
Cleared Apr 24, 1980
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813
Diagnostic Products Corp.
Chemistry · 13d
Cleared Oct 30, 1979
LIPOTROL
K792024
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025
Helena Laboratories
Chemistry · 21d
Cleared Dec 20, 1978
CONTROL, PROTEIN ELECTROPHORESIS
K781893
Sigma Chemical Co.
Chemistry · 42d
Cleared May 19, 1978
COMP. CLIN. CHEM. CONTROL SERUM-DECISION
K780552
Beckman Instruments, Inc.
Chemistry · 44d