KALLESTAD QM300 CALIBRATOR C PACK
FDA 510(k) clearance K880729 · decided 1988-03-30
Clearance details
- K-number
- K880729
- Device name
- KALLESTAD QM300 CALIBRATOR C PACK
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-23
- Decision date
- 1988-03-30
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.