The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Bile Acids Reagent Set.
| Device ID | K970120 |
| 510k Number | K970120 |
| Device Name: | BILE ACIDS REAGENT SET |
| Classification | Radioimmunoassay, Cholyglycine, Bile Acids |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Andrew Reams |
| Correspondent | Andrew Reams TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | KWW |
| CFR Regulation Number | 862.1177 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-03-24 |