The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Respiralex Latex Agglutination Test.
| Device ID | K844399 |
| 510k Number | K844399 |
| Device Name: | RESPIRALEX LATEX AGGLUTINATION TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | Cheryl West |
| Correspondent | Cheryl West ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-08 |