AGAMATRIX HEALTH MANAGER
FDA 510(k) clearance K132821 · decided 2013-11-20
Clearance details
- K-number
- K132821
- Device name
- AGAMATRIX HEALTH MANAGER
- Applicant
- Agamatrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-09
- Decision date
- 2013-11-20
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Salem, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.