NATURAL DETECTOR SYSTEM
FDA 510(k) clearance K861731 · decided 1986-11-06
Clearance details
- K-number
- K861731
- Device name
- NATURAL DETECTOR SYSTEM
- Applicant
- U.S. Health Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-06
- Decision date
- 1986-11-06
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.