The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Dryslide Coagulase.
| Device ID | K950706 |
| 510k Number | K950706 |
| Device Name: | DRYSLIDE COAGULASE |
| Classification | Plasma, Coagulase, Human, Horse And Rabbit |
| 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 | JTL |
| CFR Regulation Number | 866.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-15 |
| Decision Date | 1995-05-16 |