FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
K-ASSAY ALPHA-1 AG
K Number: K993441
·
Decision Nov 24, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
10
Applicant Total
43
Review Days
43
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Basic Information
- Device Name
- K-ASSAY ALPHA-1 AG
- K Number
- K993441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5420
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kamiya Biomedical Co.
- Date Received
- October 12, 1999
- Decision Date
- November 24, 1999
- Product Code
- LKL
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKL), ordered by most recent decision date.
N-ASSAY TIA MULTI V-NL
FDA 510(k)
FDA Class 1
·Immunology
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
FDA 510(k)
FDA Class 1
·Immunology
AL-ACID GLYCOPROTEIN RID KIT
FDA 510(k)
FDA Class 1
·Immunology
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
FDA 510(k)
FDA Class 1
·Immunology
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
FDA 510(k)
FDA Class 1
·Immunology
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
FDA 510(k)
FDA Class 1
·Immunology
Other Clearances by Kamiya Biomedical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Sep 28, 2010 | Substantially Equivalent |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Apr 29, 2010 | Substantially Equivalent |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Dec 23, 2005 | Substantially Equivalent |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Dec 10, 2004 | Substantially Equivalent |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | Jun 27, 2003 | Substantially Equivalent |
| K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR | Feb 4, 2003 | Substantially Equivalent |
| K023853 | K-ASSAY LP(A) CONTROLS | Dec 13, 2002 | Substantially Equivalent |
| K022486 | K-ASSAY HS-CRP CONTROLS | Aug 14, 2002 | Substantially Equivalent |
| K021660 | K-ASSAY LP(A) ASSAY | Jul 25, 2002 | Substantially Equivalent |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Feb 19, 2002 | Substantially Equivalent |