FDA product code KWW: Radioimmunoassay, Cholyglycine, Bile Acids
KWW is the FDA product code for radioimmunoassay, cholyglycine, bile acids. It is a Class II device, regulated under 21 CFR 862.1177 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under KWW, from 6 different applicants. The average 510(k) review took 79 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cholyglycine, Bile Acids |
| Device class | Class II |
| Regulation | 21 CFR 862.1177 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KWW clearance
Top KWW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catachem, Inc. | 1 | 2007-01-19 |
| Diazyme Laboratories | 1 | 2005-12-07 |
| Teco Diagnostics | 1 | 1997-03-24 |
| Sigma Diagnostics, Inc. | 1 | 1987-08-26 |
| Immunotech Corp. | 1 | 1981-01-16 |
1 more applicants have KWW clearances. See the full list in Caduvo.
Most recent KWW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062503 | Catachem, Inc. | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | 2007-01-19 | 147 |
| K051714 | Diazyme Laboratories | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | 2005-12-07 | 163 |
| K970120 | Teco Diagnostics | BILE ACIDS REAGENT SET | 1997-03-24 | 69 |
| K872296 | Sigma Diagnostics, Inc. | BILE ACIDS REAGENT | 1987-08-26 | 71 |
| K803296 | Immunotech Corp. | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | 1981-01-16 | 17 |
Recalls for KWW devices
openFDA lists no recalls for product code KWW.
Frequently asked questions
What is FDA product code KWW?
KWW is the FDA product code for radioimmunoassay, cholyglycine, bile acids. It is a Class II device, regulated under 21 CFR 862.1177 and reviewed by the Clinical Chemistry panel.
What device class is KWW?
Class II, regulation 21 CFR 862.1177. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWW?
Across 6 cleared submissions the average was 79 days from receipt to decision (median 70).
Which companies have the most KWW clearances?
Catachem, Inc. (1); Diazyme Laboratories (1); Teco Diagnostics (1); Sigma Diagnostics, Inc. (1); Immunotech Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KWW
- Run a recall and safety report across every KWW manufacturer
- Watch product code KWW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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