TOTAL BILE ACIDS ASSAY, MODEL DZ042A
FDA 510(k) clearance K051714 · decided 2005-12-07
Clearance details
- K-number
- K051714
- Device name
- TOTAL BILE ACIDS ASSAY, MODEL DZ042A
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2005-06-27
- Decision date
- 2005-12-07
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- KWW
- Device class
- 2
- Regulation number
- 862.1177
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (K062503) | Catachem, Inc. | 2007-01-19 |
| BILE ACIDS REAGENT SET (K970120) | Teco Diagnostics | 1997-03-24 |
| BILE ACIDS REAGENT (K872296) | Sigma Diagnostics, Inc. | 1987-08-26 |
| ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (K803296) | Immunotech Corp. | 1981-01-16 |
| CONJUGATED BILE ACIDS RIA KIT (K781337) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 |
Recalls involving this device
No recalls on record reference this clearance.