MID STREAM PREGNANCY TEST
FDA 510(k) clearance K023037 · decided 2003-04-09
Clearance details
- K-number
- K023037
- Device name
- MID STREAM PREGNANCY TEST
- Applicant
- Advanced Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-12
- Decision date
- 2003-04-09
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- So. Plainfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.