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 |