The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Tri-count Calibrator.
| Device ID | K844708 |
| 510k Number | K844708 |
| Device Name: | TRI-COUNT CALIBRATOR |
| Classification | Calibrator For Red-cell And White-cell Counting |
| 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 | KSA |
| CFR Regulation Number | 864.8185 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-03-05 |