ONE STEP HCG URINE/SERUM TEST
FDA 510(k) clearance K072500 · decided 2009-04-21
Clearance details
- K-number
- K072500
- Device name
- ONE STEP HCG URINE/SERUM TEST
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-05
- Decision date
- 2009-04-21
- Days to decision
- 594 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Yardley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.