NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
FDA 510(k) clearance K101185 · decided 2011-09-20
Clearance details
- K-number
- K101185
- Device name
- NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
- Applicant
- Iris Molecular Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2010-04-28
- Decision date
- 2011-09-20
- Days to decision
- 510 days
- Clearance type
- Traditional
- Product code
- OWM
- Device class
- 2
- Regulation number
- 866.6040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.