The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Spottest 10% Sodium Desoxycholate.
| Device ID | K870716 |
| 510k Number | K870716 |
| Device Name: | SPOTTEST 10% SODIUM DESOXYCHOLATE |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | M. T Robert |
| Correspondent | M. T Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-20 |
| Decision Date | 1987-04-03 |