FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K Number: K093137
·
Decision Sep 28, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
21
Applicant Total
43
Review Days
358
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Basic Information
- Device Name
- K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
- K Number
- K093137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kamiya Biomedical Co.
- Date Received
- October 5, 2009
- Decision Date
- September 28, 2010
- Product Code
- NDY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| NDY | Test, Cystatin C | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDY), ordered by most recent decision date.
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COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
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DIAZYME CYSTATIN C POC TEST KIT
FDA 510(k)
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Other Clearances by Kamiya Biomedical Co.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K012422 | K-ASSAY D-DIMER CONTROLS | Aug 21, 2001 | Substantially Equivalent |