The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Adenolex (r) Latex Agglutination Test.
| Device ID | K864645 |
| 510k Number | K864645 |
| Device Name: | ADENOLEX (R) LATEX AGGLUTINATION TEST |
| Classification | Antigens, Cf (including Cf Control), Adenovirus 1-33 |
| Applicant | ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | Julie Demarco |
| Correspondent | Julie Demarco ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | GOD |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-25 |
| Decision Date | 1987-06-04 |