The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Respirastick Enzyme Immunoassay Test.
| Device ID | K862475 |
| 510k Number | K862475 |
| Device Name: | RESPIRASTICK ENZYME IMMUNOASSAY TEST |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | De Marco |
| Correspondent | De Marco ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-09-16 |