The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Varicella Zoster Igg Clin-elisa Test Kit.
| Device ID | K900688 |
| 510k Number | K900688 |
| Device Name: | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| 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 | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-05-15 |