The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for H-1 Setpoint Platelet And Rbc/wbc Calibrators.
| Device ID | K864664 |
| 510k Number | K864664 |
| Device Name: | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS |
| Classification | Calibrator For Red-cell And White-cell Counting |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | KSA |
| CFR Regulation Number | 864.8185 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-28 |
| Decision Date | 1987-02-06 |