FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K Number: K993375
·
Decision Dec 20, 1999
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
15
Applicant Total
3
Review Days
74
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Basic Information
- Device Name
- CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
- K Number
- K993375
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 864.8150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Diagnostic Solutions, Inc.
- Date Received
- October 7, 1999
- Decision Date
- December 20, 1999
- Product Code
- KRX
- 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 |
|---|---|---|---|
| KRX | Calibrator For Cell Indices | FDA class 2 | Hematology |
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