The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Tri-count 16.
| Device ID | K902389 |
| 510k Number | K902389 |
| Device Name: | TRI-COUNT 16 |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | HEMATRONIX, INC. 1505 CAPITAL AVE. Plano, TX 75074 |
| Contact | James D Lapicola |
| Correspondent | James D Lapicola HEMATRONIX, INC. 1505 CAPITAL AVE. Plano, TX 75074 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003007 | K902389 | 000 |
| 00847661002994 | K902389 | 000 |
| 00847661002987 | K902389 | 000 |
| 00847661002970 | K902389 | 000 |
| 00847661002963 | K902389 | 000 |