ONE-STEP PREGNANCY TEST
FDA 510(k) clearance K031271 · decided 2003-06-17
Clearance details
- K-number
- K031271
- Device name
- ONE-STEP PREGNANCY TEST
- Applicant
- Amerisource Pharmacal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-22
- Decision date
- 2003-06-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.