POLY STAT HCG TEST
FDA 510(k) clearance K012559 · decided 2001-10-16
Clearance details
- K-number
- K012559
- Device name
- POLY STAT HCG TEST
- Applicant
- Bion Diagnostic Sciences
- Decision
- Substantially Equivalent
- Date received
- 2001-08-08
- Decision date
- 2001-10-16
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.