The following data is part of a premarket notification filed by American Scientific Products with the FDA for Coagulase Plasma-citrated & Edta.
| Device ID | K822988 |
| 510k Number | K822988 |
| Device Name: | COAGULASE PLASMA-CITRATED & EDTA |
| Classification | Plasma, Coagulase, Human, Horse And Rabbit |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTL |
| CFR Regulation Number | 866.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1982-11-05 |