The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon H.1 System, T Lymphocytes Method.
| Device ID | K860830 |
| 510k Number | K860830 |
| Device Name: | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD |
| Classification | Assay, T Lymphocyte Surface Marker |
| 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 | LIZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-05 |
| Decision Date | 1986-09-08 |