Clearance Summary
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K861773, sponsored by Zygotek Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1986-07-07.
- Submission: K861773
- Applicant / Sponsor: Zygotek Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5800
- Decision date: 1986-07-07
Classification & Regulation
This clearance is catalogued under FDA product code DGB and 21 CFR 866.5800, within the Immunology review panel as a Class I device.