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 |