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

Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

21 CFR 862.1187 / Clinical Chemistry
FDA source (opens on fda.gov)

KWX is the FDA product code for Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids, a class II device type, regulated under 21 CFR 862.1187. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KWX
Device name
Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
Regulation
21 CFR 862.1187
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code KWX

By decision year
2 clearances under product code KWX with a decision year between 1998 and 2000, 1998 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KWX by decision year
YearClearances
19981
20001

Applicants with the most clearances

Product code KWX
Applicants holding the most 510(k) clearances under product code KWX
ApplicantClearances
Marukin Diagnostics1
Marukin Shoyu Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KWX.