510(k) K062503
- Device
- CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
- Applicant
- CATACHEM, INC.
- 510(k) number
- K062503
- Product code
- KWW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-19
- Date received
- 2006-08-25
- Regulation
- 862.1177
- Classification name
- Radioimmunoassay, Cholyglycine, Bile Acids
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUIS P LEON
- Address
- 955 Connecticut Ave. Suite 4106 Bridgeport CT US 06607 06607
FDA Registration Numbers#
- 2434178
- 2032900
- 9681576
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | 2005-12-07 |
| K970120 | BILE ACIDS REAGENT SET | Teco Diagnostics | 1997-03-24 |
| K872296 | BILE ACIDS REAGENT | Sigma Diagnostics, Inc. | 1987-08-26 |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Immunotech Corp. | 1981-01-16 |
| K781337 | CONJUGATED BILE ACIDS RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 |
Legacy Summary#
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FDA Review#
Decision Summary