The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Bovine Blood Cells In Alsevers Citrate/defibrinate.
| Device ID | K861815 |
| 510k Number | K861815 |
| Device Name: | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE |
| Classification | Sera, Animal And Human |
| Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Contact | Noel |
| Correspondent | Noel HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-09 |
| Decision Date | 1986-05-20 |