The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Sigms B-hydroxybutarate Procedure No. 310-uv.
| Device ID | K850368 |
| 510k Number | K850368 |
| Device Name: | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Quincy E Crider |
| Correspondent | Quincy E Crider SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-31 |
| Decision Date | 1985-08-30 |