The following data is part of a premarket notification filed by Applications Lab with the FDA for Spq Test System For Alpha, - Antitrypsin.
| Device ID | K850587 |
| 510k Number | K850587 |
| Device Name: | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | APPLICATIONS LAB 10 NONESUCH RD. Scarborough, ME 04074 |
| Contact | Glenn R Irish |
| Correspondent | Glenn R Irish APPLICATIONS LAB 10 NONESUCH RD. Scarborough, ME 04074 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-03-14 |