The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Dpa-1 System Rf Method.
| Device ID | K894574 |
| 510k Number | K894574 |
| Device Name: | TECHNICON DPA-1 SYSTEM RF METHOD |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard Dwarica |
| Correspondent | Leonard Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-21 |
| Decision Date | 1989-08-10 |