ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
FDA 510(k) clearance K861773 · decided 1986-07-07
Clearance details
- K-number
- K861773
- Device name
- ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
- Applicant
- Zygotek Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-07
- Decision date
- 1986-07-07
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DGB
- Device class
- 1
- Regulation number
- 866.5800
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Springfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.