The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Antibody Reagent Set Ii For Aat.
| Device ID | K890415 |
| 510k Number | K890415 |
| Device Name: | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Contact | Glenn Irish |
| Correspondent | Glenn Irish ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 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 | 1989-01-24 |
| Decision Date | 1989-02-17 |