The following data is part of a premarket notification filed by General Diagnostics with the FDA for General Diagnostics Platelet Antibody.
| Device ID | K841465 |
| 510k Number | K841465 |
| Device Name: | GENERAL DIAGNOSTICS PLATELET ANTIBODY |
| Classification | Kit, Igg, Platelet Associated |
| Applicant | GENERAL DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LLG |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-07-02 |