The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Dpa-1 Immunoglobulin M.
| Device ID | K883493 |
| 510k Number | K883493 |
| Device Name: | TECHNICON DPA-1 IMMUNOGLOBULIN M |
| Classification | Igm, Ferritin, Antigen, Antiserum, Control |
| 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 | DFL |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-09-22 |