The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Buffer, Collagen Reagent And Diluent.
| Device ID | K781710 |
| 510k Number | K781710 |
| Device Name: | BUFFER, COLLAGEN REAGENT AND DILUENT |
| Classification | Aggregrometer, Platelet |
| Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBX |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-05 |
| Decision Date | 1978-10-24 |