The following data is part of a premarket notification filed by Orgentec with the FDA for Orgentec Enascreen Pin Immuno Assay.
Device ID | K955133 |
510k Number | K955133 |
Device Name: | ORGENTEC ENASCREEN PIN IMMUNO ASSAY |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
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 | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-09 |
Decision Date | 1996-03-20 |