The following data is part of a premarket notification filed by Bellhouse Medical, Inc. with the FDA for Blood Platelet Assay Method & Apparatus.
| Device ID | K862302 |
| 510k Number | K862302 |
| Device Name: | BLOOD PLATELET ASSAY METHOD & APPARATUS |
| Classification | System, Automated Platelet Aggregation |
| Applicant | BELLHOUSE MEDICAL, INC. INTERNATIONAL SQUARE 1825 EYE ST. N.W., SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney BELLHOUSE MEDICAL, INC. INTERNATIONAL SQUARE 1825 EYE ST. N.W., SUITE 400 Washington, DC 20006 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-07-31 |