DEL · Lipoprotein X, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5590 · Class 1
Overview
| Product Code | DEL |
|---|---|
| Device Name | Lipoprotein X, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5590 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | Nov 15, 2001 | SESE |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | Apr 26, 1990 | SESE |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | Mar 2, 1990 | SESE |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | Oct 6, 1989 | SESE |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | Jun 21, 1989 | SESE |
Top Applicants
- Sigma Chemical Co. — 2 clearances
- Catachem, Inc. — 1 clearance
- Medical Marketing Consultants, Inc. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
