FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
FDA 510(k) clearance K945519 · decided 1995-11-03
Clearance details
- K-number
- K945519
- Device name
- FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
- Applicant
- Pharmaquest Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-09
- Decision date
- 1995-11-03
- Days to decision
- 359 days
- Clearance type
- Traditional
- Product code
- MPG
- Device class
- 1
- Regulation number
- 862.1505
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Rafael, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.