CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
FDA 510(k) clearance K062503 · decided 2007-01-19
Clearance details
- K-number
- K062503
- Device name
- CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
- Applicant
- Catachem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-25
- Decision date
- 2007-01-19
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- KWW
- Device class
- 2
- Regulation number
- 862.1177
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bridgeport, CT, 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 |
|---|---|---|
| TOTAL BILE ACIDS ASSAY, MODEL DZ042A (K051714) | Diazyme Laboratories | 2005-12-07 |
| 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.