The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Immunoglobulins A,g,m,d,e Immunological Test.
| Device ID | K861167 |
| 510k Number | K861167 |
| Device Name: | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST |
| Classification | Iga, Antigen, Antiserum, Control |
| Applicant | ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Contact | Glenn R Irish |
| Correspondent | Glenn R Irish ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Product Code | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-04-25 |