KXS · Class II · 21 CFR 862.3630

FDA Product Code KXS: Radioimmunoassay, Methaqualone

Leading manufacturers include Syva Co., Diagnostic Products Corp. and Roche Diagnostic Systems, Inc..

16
Total
16
Cleared
51d
Avg days
1981
Since

FDA 510(k) Cleared Radioimmunoassay, Methaqualone Devices (Product Code KXS)

16 devices
1–16 of 16
Cleared Jan 27, 2000
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986
Syva Co.
Toxicology · 64d
Cleared Mar 04, 1996
SYNCHRON SYSTEMS METHAQUALONE REAGENT
K955676
Beckman Instruments, Inc.
Toxicology · 80d
Cleared Apr 05, 1995
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187
Roche Diagnostic Systems, Inc.
Toxicology · 163d
Cleared May 13, 1992
SYVA EMIT II METHAQUALONE ASSAY
K921013
Syva Co.
Toxicology · 71d
Cleared Nov 13, 1987
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199
Syva Co.
Toxicology · 14d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759
Diagnostic Products Corp.
Toxicology · 41d
Cleared Mar 19, 1987
COAT-A-COUNT METHAQUALONE TKMQ1
K870935
Diagnostic Products Corp.
Toxicology · 10d
Cleared Oct 05, 1984
EMIT 700 METHAQUALONE ASSAY
K843605
Syva Co.
Toxicology · 22d
Cleared Mar 22, 1984
EMIT ST URINE METHAQUALONE ASSAY
K840164
Syva Co.
Toxicology · 66d
Cleared Jul 27, 1982
EMIT D.A.V. METHAQUALONE ASSAY
K822051
Syva Co.
Toxicology · 14d
Cleared Jun 24, 1982
EMIT ST URINE METHAGUALONE ASSAY
K821768
Syva Co.
Chemistry · 9d

About Product Code KXS - Regulatory Context