The following data is part of a premarket notification filed by Gainor Medical with the FDA for Clear Porous Plastic-hypoallergenic.
| Device ID | K840948 |
| 510k Number | K840948 |
| Device Name: | CLEAR POROUS PLASTIC-HYPOALLERGENIC |
| Classification | Instrument, Automated Platelet Counting |
| Applicant | GAINOR MEDICAL MD |
| Product Code | GKX |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-06 |
| Decision Date | 1984-08-14 |