The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Alpha1antitrypsin For Technicon Dpa-1(tm) System.
| Device ID | K882446 |
| 510k Number | K882446 |
| Device Name: | ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM |
| Classification | Alpha-1-antitrypsin, 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 | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-07-08 |