The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Retic-quinox.
| Device ID | K993496 |
| 510k Number | K993496 |
| Device Name: | RETIC-QUINOX |
| 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 | 1999-10-15 |
| Decision Date | 1999-11-30 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RETIC-QUINOX 76339301 2682918 Dead/Cancelled |
BIO-RAD LABORATORIES, INC. 2001-11-19 |