CHEMMATE KAPPA
FDA 510(k) clearance K973391 · decided 1997-10-03
Clearance details
- K-number
- K973391
- Device name
- CHEMMATE KAPPA
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-10
- Decision date
- 1997-10-03
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DEM
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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