Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System
FDA 510(k) K945519 · Pharmaquest Corp.
510(k) numberK945519
Submission
- Device name
- Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System
- Applicant
- Pharmaquest Corp.
San Rafael, CA, US - Received
- November 9, 1994
- Decision date
- November 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MPG – Urinary Carbohydrate Analysis Kit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1505
- Specialty
- Clinical Chemistry
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Questions and answers
When was Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System cleared by the FDA?
Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis System (K945519) received a 510(k) decision of Substantially Equivalent on November 3, 1995, 359 days after the submission was received.
What is the product code of K945519?
The FDA product code is MPG – Urinary Carbohydrate Analysis Kit, a Class I (low risk) device regulated under 21 CFR 862.1505.