ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
FDA 510(k) clearance K852834 · decided 1985-08-08
Clearance details
- K-number
- K852834
- Device name
- ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
- Applicant
- Ortho Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-02
- Decision date
- 1985-08-08
- Days to decision
- 37 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.