Atlas FDA

KXS

16 FDA 510(k) clearances · Product code

41 daysmedian time to decision
113 days90th percentile
16clearances measured

FDA profile

Official device name
Radioimmunoassay, Methaqualone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3630
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (K011164)Syva Co., Dade Behring, Inc.2001-05-10
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (K993986)Syva Co.2000-01-27
SYNCHRON SYSTEMS METHAQUALONE REAGENT (K955676)Beckman Instruments, Inc.1996-03-04
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187)Roche Diagnostic Systems, Inc.1995-04-05
METHAQUALONE ENZYME IMMUNOASSAY (K940123)Diagnostic Reagents, Inc.1994-05-03
SYVA EMIT II METHAQUALONE ASSAY (K921013)Syva Co.1992-05-13
REVISED LABELING FOR METHAQUALONE TEST KIT (K874272)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (K874199)Syva Co.1987-10-28
LABELING CHANGE COAT-A-COUNT METHAQUALONE (K873759)Diagnostic Products Corp.1987-10-15
COAT-A-COUNT METHAQUALONE TKMQ1 (K870935)Diagnostic Products Corp.1987-03-19
EMIT 700 METHAQUALONE ASSAY (K843605)Syva Co.1984-10-05
EMIT ST URINE METHAQUALONE ASSAY (K840164)Syva Co.1984-03-22
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461)Hoffmann-La Roche, Inc.1983-03-24
EMIT D.A.V. METHAQUALONE ASSAY (K822051)Syva Co.1982-07-27
EMIT ST URINE METHAGUALONE ASSAY (K821768)Syva Co.1982-06-24
AGGLUTEX METHAQUALONE TEST KIT (K812987)Hoffmann-La Roche, Inc.1981-12-22

Track KXS automatically

Every clearance here is in the API, with alerts when new ones post.