The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Alpha-1-antitrypsin, Fitc, Antigen.
| Device ID | K840867 |
| 510k Number | K840867 |
| Device Name: | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN |
| Classification | Alpha-1-antitrypsin, Fitc, Antigen, Antiserum, Control |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DEI |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-05-11 |