The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Tri-count.
| Device ID | K851375 |
| 510k Number | K851375 |
| Device Name: | TRI-COUNT |
| 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 | 1985-04-08 |
| Decision Date | 1985-07-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRI-COUNT 72416284 0954813 Dead/Cancelled |
BIO-RAD LABORATORIES 1972-02-18 |