The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Bile Acids Calibrator.
| Device ID | K872451 |
| 510k Number | K872451 |
| Device Name: | BILE ACIDS CALIBRATOR |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516741866 | K872451 | 000 |
| 05391516741859 | K872451 | 000 |