BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
FDA 510(k) clearance K023944 · decided 2003-02-11
Clearance details
- K-number
- K023944
- Device name
- BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-26
- Decision date
- 2003-02-11
- Days to decision
- 77 days
- Clearance type
- Abbreviated
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.