PRAXSYS RELIA TSH TEST
FDA 510(k) clearance K011527 · decided 2001-08-07
Clearance details
- K-number
- K011527
- Device name
- PRAXSYS RELIA TSH TEST
- Applicant
- Praxsys Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-17
- Decision date
- 2001-08-07
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Ramon, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.