CALCITONIN KIT MITSUBISHI YUKA
FDA 510(k) clearance K912536 · decided 1991-07-18
Clearance details
- K-number
- K912536
- Device name
- CALCITONIN KIT MITSUBISHI YUKA
- Applicant
- Mitsubishi Yuka America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-07
- Decision date
- 1991-07-18
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JKR
- Device class
- 2
- Regulation number
- 862.1140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.