The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Meter Trax.
| Device ID | K904461 |
| 510k Number | K904461 |
| Device Name: | METER TRAX |
| Classification | Mixture, Hematology Quality Control |
| Applicant | HEMATRONIX, INC. 1505 CAPITAL AVE. Plano, TX 75074 |
| Contact | Jim Lapicola |
| Correspondent | Jim Lapicola HEMATRONIX, INC. 1505 CAPITAL AVE. Plano, TX 75074 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1990-10-26 |