Clearance Summary
ANTIBODY TO VARICELLA-ZOSTER VIRUS received FDA 510(k) clearance under submission number K800787, sponsored by Electro-Nucleonics Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1980-07-14.
- Submission: K800787
- Applicant / Sponsor: Electro-Nucleonics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 1980-07-14
Classification & Regulation
This clearance is catalogued under FDA product code GGW and 21 CFR 864.7925, within the Hematology review panel as a Class II device.