PROPOXPHENE EIA TEST
FDA 510(k) clearance K943414 · decided 1994-09-09
Clearance details
- K-number
- K943414
- Device name
- PROPOXPHENE EIA TEST
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-15
- Decision date
- 1994-09-09
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JXN
- Device class
- 2
- Regulation number
- 862.3700
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.