FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K Number: K073178
·
Decision Dec 27, 2007
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
79
Review Days
44
Basic Information
- Device Name
- HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
- K Number
- K073178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R & D SYSTEMS, INC.
- Date Received
- November 13, 2007
- Decision Date
- December 27, 2007
- Product Code
- JPK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | Jan 29, 2010 | Substantially Equivalent |
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| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | Nov 26, 2007 | Substantially Equivalent |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | Nov 20, 2007 | Substantially Equivalent |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | Aug 20, 2007 | Substantially Equivalent |
| K070334 | R&D SICKLE QC CONTROL | Mar 29, 2007 | Substantially Equivalent |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | Jul 10, 2006 | Substantially Equivalent |