The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Testpoint Assayed Hematology Low & High.
| Device ID | K850250 |
| 510k Number | K850250 |
| Device Name: | TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH |
| Classification | Mixture, Hematology Quality Control |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Dwarica |
| Correspondent | Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-04-01 |