510(k) K970120
- Device
- BILE ACIDS REAGENT SET
- Applicant
- TECO DIAGNOSTICS
- 510(k) number
- K970120
- Product code
- KWW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-24
- Date received
- 1997-01-14
- 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
- ANDREW REAMS
- Address
- 4925 E. Hunter Ave. Anaheim CA US 92807 92807
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 |
|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Catachem, Inc. | 2007-01-19 |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | 2005-12-07 |
| 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#
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