Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control are reagents comprising the antigen, antiserum, and control materials used to measure alpha-1-acid glycoprotein (also known as orosomucoid), an acute-phase protein whose serum levels rise during inflammation, infection, or tissue injury. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is LKL, regulated under 21 CFR 866.5420, within the Immunology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LKL
- Device Class
- FDA class 1
- Regulation Number
- 866.5420
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993441 | K-ASSAY ALPHA-1 AG | Nov 24, 1999 | Substantially Equivalent | Kamiya Biomedical Co. |
| K964299 | N-ASSAY TIA MULTI V-NL | Jul 14, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Mar 24, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K922417 | AL-ACID GLYCOPROTEIN RID KIT | Aug 20, 1992 | Substantially Equivalent | The Binding Site, Ltd. |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Nov 13, 1990 | Substantially Equivalent | Reagents Applications, Inc. |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Nov 04, 1988 | Substantially Equivalent | Technicon Instruments Corp. |
| K873868 | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Oct 20, 1987 | Substantially Equivalent | Unipath , Ltd. |
| K862087 | SANTEST 1AP | Dec 03, 1986 | Substantially Equivalent | Scientific Sales Intl., Inc. |
| K861336 | IAP PLATE TEST | Apr 25, 1986 | Substantially Equivalent | Scientific Sales Intl., Inc. |
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Jun 01, 1984 | Substantially Equivalent | Tago, Inc. |
| K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Jul 19, 1983 | Substantially Equivalent | Kent Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.