FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-ASSAY LP(A) ASSAY
K Number: K021660
·
Decision Jul 25, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
43
Review Days
66
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Basic Information
- Device Name
- K-ASSAY LP(A) ASSAY
- K Number
- K021660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kamiya Biomedical Co.
- Date Received
- May 20, 2002
- Decision Date
- July 25, 2002
- Product Code
- DFC
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
FDA 510(k)
FDA Class 2
·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 |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Feb 19, 2002 | Substantially Equivalent |
| K012422 | K-ASSAY D-DIMER CONTROLS | Aug 21, 2001 | Substantially Equivalent |