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 |