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

Radioimmunoassay, Cholyglycine, Bile Acids

21 CFR 862.1177 / Clinical Chemistry
FDA source (opens on fda.gov)

KWW is the FDA product code for Radioimmunoassay, Cholyglycine, Bile Acids, a class II device type, regulated under 21 CFR 862.1177. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KWW
Device name
Radioimmunoassay, Cholyglycine, Bile Acids
Regulation
21 CFR 862.1177
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
6
Ingested recalls
0

Clearances, product code KWW

By decision year
6 clearances under product code KWW with a decision year between 1978 and 2007, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KWW by decision year
YearClearances
19781
19811
19871
19971
20051
20071

Applicants with the most clearances

Product code KWW
Applicants holding the most 510(k) clearances under product code KWW
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Catachem, Inc.1
Diazyme Laboratories, Inc.1
IMMUNOTECH s.r.o.1
Sigma Diagnostics, Inc.1
Teco Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code