The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Modification To Lipoprint System, Ldl Subfractions.
| Device ID | K013662 |
| 510k Number | K013662 |
| Device Name: | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Gebhard Neyer |
| Correspondent | Gebhard Neyer QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-03-08 |
| Summary: | summary |