The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Dispens-o-disc(tm) Nitrocefin.
| Device ID | K941016 |
| 510k Number | K941016 |
| Device Name: | DISPENS-O-DISC(TM) NITROCEFIN |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | DIFCO LABORATORIES, INC. P. O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | David W Gates |
| Correspondent | David W Gates 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 | 1994-03-03 |
| Decision Date | 1994-06-30 |