QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
FDA 510(k) clearance K841864 · decided 1984-07-11
Clearance details
- K-number
- K841864
- Device name
- QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-04
- Decision date
- 1984-07-11
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- DEH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.