The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Bile Acids Reagent.
| Device ID | K872296 |
| 510k Number | K872296 |
| Device Name: | BILE ACIDS REAGENT |
| Classification | Radioimmunoassay, Cholyglycine, Bile Acids |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KWW |
| CFR Regulation Number | 862.1177 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-16 |
| Decision Date | 1987-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516741927 | K872296 | 000 |
| 05391516741910 | K872296 | 000 |
| 05391516741903 | K872296 | 000 |
| 05391516741880 | K872296 | 000 |
| 05391516741873 | K872296 | 000 |