PHENYTION EIA TEST
FDA 510(k) clearance K945725 · decided 1995-02-03
Clearance details
- K-number
- K945725
- Device name
- PHENYTION EIA TEST
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-22
- Decision date
- 1995-02-03
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- DIP
- Device class
- 2
- Regulation number
- 862.3350
- 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.