The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Bile Acids Controls.
| Device ID | K873342 |
| 510k Number | K873342 |
| Device Name: | BILE ACIDS CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-19 |
| Decision Date | 1987-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516741897 | K873342 | 000 |