The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Total Bile Acids Assay, Model Dz042a.
| Device ID | K051714 |
| 510k Number | K051714 |
| Device Name: | TOTAL BILE ACIDS ASSAY, MODEL DZ042A |
| Classification | Radioimmunoassay, Cholyglycine, Bile Acids |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Huan Tran |
| Correspondent | Huan Tran DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | KWW |
| CFR Regulation Number | 862.1177 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2005-12-07 |
| Summary: | summary |