The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Rubella Elisa Test System Catalog Number: 4540.
| Device ID | K860145 |
| 510k Number | K860145 |
| Device Name: | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-15 |
| Decision Date | 1986-07-14 |