510(k) K861773
K861773 is an FDA 510(k) premarket notification submitted by Zygotek Systems, Inc. for the device "ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 7, 1986. The device falls under product code DGB (Seminal Fluid, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1986
- Date Received
- May 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Seminal Fluid, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5800
- Review Panel
- HE
- Submission Type