The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Anti-ss-b(la) Pin Immuno Assay.
Device ID | K954832 |
510k Number | K954832 |
Device Name: | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
Applicant | ORGENTEC P.O. BOX 451 Windham, NH 03087 |
Contact | Richard Conley |
Correspondent | Richard Conley ORGENTEC P.O. BOX 451 Windham, NH 03087 |
Product Code | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-20 |
Decision Date | 1996-04-18 |