QUANTIMETRIC PLUS KAPPA REAGENT KIT
FDA 510(k) clearance K855008 · decided 1986-02-26
Clearance details
- K-number
- K855008
- Device name
- QUANTIMETRIC PLUS KAPPA REAGENT KIT
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-16
- Decision date
- 1986-02-26
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- DFH
- Device class
- 2
- Regulation number
- 866.5550
- 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.