The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Rubeola Igg Clin-elisa Test System, Cat. #4600.
| Device ID | K891990 |
| 510k Number | K891990 |
| Device Name: | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Contact | Helen Schneider |
| Correspondent | Helen Schneider CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Product Code | LJB |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-06-15 |