Lipoprotein X, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting lipoprotein X, an abnormal lipoprotein particle found in patients with cholestasis or lecithin-cholesterol acyltransferase (LCAT) deficiency, including antigen, antiserum, and control components for laboratory immunoassay applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DEL, regulated under 21 CFR 866.5590, within the Immunology specialty.
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Basic Information
- Product Code
- DEL
- Device Class
- FDA class 1
- Regulation Number
- 866.5590
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Nov 15, 2001 | Substantially Equivalent | Roche Diagnostics Corp. |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Apr 26, 1990 | Substantially Equivalent | Sigma Chemical Co. |
| K900124 | APOLIPOPROTEIN B (APO B) | Mar 02, 1990 | Substantially Equivalent | Sigma Chemical Co. |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Oct 06, 1989 | Substantially Equivalent | Medical Marketing Consultants, Inc. |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Jun 21, 1989 | Substantially Equivalent | Catachem, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.