The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Face (fluorophore-assisted-carbohydrate-electrophoresis) Urinary Carbohydrate Analysis System.
| Device ID | K945519 |
| 510k Number | K945519 |
| Device Name: | FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM |
| Classification | Urinary Carbohydrate Analysis Kit |
| Applicant | PHARMAQUEST CORP. 4470 REDWOOD HIGH WAY SUITE 101 San Rafael, CA 94903 |
| Contact | Richard J D'agostino |
| Correspondent | Richard J D'agostino PHARMAQUEST CORP. 4470 REDWOOD HIGH WAY SUITE 101 San Rafael, CA 94903 |
| Product Code | MPG |
| CFR Regulation Number | 862.1505 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-11-03 |