NEOSCREEN ELISA HYDROXYPROGESTERONE
FDA 510(k) clearance K940233 · decided 1994-12-28
Clearance details
- K-number
- K940233
- Device name
- NEOSCREEN ELISA HYDROXYPROGESTERONE
- Applicant
- Pantex
- Decision
- Substantially Equivalent
- Date received
- 1994-01-18
- Decision date
- 1994-12-28
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- JLX
- Device class
- 1
- Regulation number
- 862.1395
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.