The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Tri-count Laser.
| Device ID | K843485 |
| 510k Number | K843485 |
| Device Name: | TRI-COUNT LASER |
| Classification | Mixture, Hematology Quality Control |
| Applicant | HEMATOLOGY MARKETING ASSOC. P.O. BOX 6756 Concord, CA 94524 |
| Contact | James Lapicola |
| Correspondent | James Lapicola HEMATOLOGY MARKETING ASSOC. P.O. BOX 6756 Concord, CA 94524 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-12-12 |