ACUSCREEN
FDA 510(k) clearance K822782 · decided 1982-10-08
Clearance details
- K-number
- K822782
- Device name
- ACUSCREEN
- Applicant
- Ortho Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-14
- Decision date
- 1982-10-08
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- GGW
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.