510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KXSClass II

Radioimmunoassay, Methaqualone

21 CFR 862.3630 / Clinical Toxicology
FDA source (opens on fda.gov)

KXS is the FDA product code for Radioimmunoassay, Methaqualone, a class II device type, regulated under 21 CFR 862.3630. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KXS
Device name
Radioimmunoassay, Methaqualone
Regulation
21 CFR 862.3630
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
0

Clearances, product code KXS

By decision year
16 clearances under product code KXS with a decision year between 1981 and 2001, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KXS by decision year
YearClearances
19811
19822
19831
19842
19874
19921
19941
19951
19961
20001
20011

Applicants with the most clearances

Product code KXS
Applicants holding the most 510(k) clearances under product code KXS
ApplicantClearances
Syva Co.3
Siemens Healthcare Diagnostics Inc.2
Hoffmann-La Roche, Inc.2
Roche Diagnostic Systems, Inc.2
Syva Co.2
Beckman Instruments, Inc.1
Diagnostic Reagents, Inc.1
Syva Co.1
Syva Co.1
Syva Co., Dade Behring, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code