510(k) K945519
- Device
- FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
- Applicant
- PHARMAQUEST CORP.
- 510(k) number
- K945519
- Product code
- MPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-03
- Date received
- 1994-11-09
- Regulation
- 862.1505
- Classification name
- Urinary Carbohydrate Analysis Kit
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD J D'AGOSTINO
- Address
- 4470 Redwood High Way Suite 101 San Rafael CA US 94903 94903
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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