BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
FDA 510(k) clearance K992791 · decided 1999-11-12
Clearance details
- K-number
- K992791
- Device name
- BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
- Applicant
- Brahms Diagnostica, LLC
- Decision
- Substantially Equivalent
- Date received
- 1999-08-19
- Decision date
- 1999-11-12
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.