The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Tri-count 20.
| Device ID | K960471 |
| 510k Number | K960471 |
| Device Name: | TRI-COUNT 20 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia, CA 94510 |
| Contact | James D Lapicola |
| Correspondent | James D Lapicola HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia, CA 94510 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-01 |
| Decision Date | 1996-03-20 |