DETECTACULT
FDA 510(k) clearance K854619 · decided 1986-03-03
Clearance details
- K-number
- K854619
- Device name
- DETECTACULT
- Applicant
- Immunostics Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-18
- Decision date
- 1986-03-03
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Metuchen, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.