FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-ASSAY HAPTOGLOBIN
K Number: K993480
·
Decision Nov 24, 1999
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
17
Applicant Total
43
Review Days
41
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Basic Information
- Device Name
- K-ASSAY HAPTOGLOBIN
- K Number
- K993480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5460
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kamiya Biomedical Co.
- Date Received
- October 14, 1999
- Decision Date
- November 24, 1999
- Product Code
- DAD
- 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 |
|---|---|---|---|
| DAD | Haptoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
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|---|---|---|---|
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| 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 |
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| 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 |