HEMOGLOBIN ELECTROPHORESIS METH ON THE-
FDA 510(k) clearance K831055 · decided 1983-06-08
Clearance details
- K-number
- K831055
- Device name
- HEMOGLOBIN ELECTROPHORESIS METH ON THE-
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-01
- Decision date
- 1983-06-08
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JBO
- Device class
- 2
- Regulation number
- 864.7275
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.