FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CBC-4K HEMATOLOGY CONTROL
K Number: K003874
·
Decision Jan 12, 2001
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
79
Review Days
28
Basic Information
- Device Name
- CBC-4K HEMATOLOGY CONTROL
- K Number
- K003874
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R & D SYSTEMS, INC.
- Date Received
- December 15, 2000
- Decision Date
- January 12, 2001
- 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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|---|---|---|---|
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| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | Dec 27, 2007 | Substantially Equivalent |
| 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 |