Product code KXS— Clinical Toxicology
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
- Classification name
- Radioimmunoassay, Methaqualone
- Device class
- Class 2
- Regulation
- 21 CFR 862.3630
- Advisory panel
- Clinical Toxicology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code KXS
FDA has cleared devices under product code KXS between 1981 and 2001, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 2000
- 1996
- 1995
- 1994
- 1992
- 1987
- 1984
- 1983
- 1982
- 1981
Top applicants under product code KXS
Recent clearances under product code KXS
- K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
- K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
- K955676 — SYNCHRON SYSTEMS METHAQUALONE REAGENT
- K945187 — ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
- K940123 — METHAQUALONE ENZYME IMMUNOASSAY
- K921013 — SYVA EMIT II METHAQUALONE ASSAY
- K874272 — REVISED LABELING FOR METHAQUALONE TEST KIT
- K874199 — REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
- K873759 — LABELING CHANGE COAT-A-COUNT METHAQUALONE
- K870935 — COAT-A-COUNT METHAQUALONE TKMQ1
- K843605 — EMIT 700 METHAQUALONE ASSAY
- K840164 — EMIT ST URINE METHAQUALONE ASSAY
- K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
- K822051 — EMIT D.A.V. METHAQUALONE ASSAY
- K821768 — EMIT ST URINE METHAGUALONE ASSAY
- K812987 — AGGLUTEX METHAQUALONE TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.