FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MS 4/5 HEMATOLOGY ANALYZER
K Number: K050421
·
Decision Aug 31, 2005
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
2
Review Days
194
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Basic Information
- Device Name
- MS 4/5 HEMATOLOGY ANALYZER
- K Number
- K050421
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Melet Schloesing Laboratories USA
- Date Received
- February 18, 2005
- Decision Date
- August 31, 2005
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Melet Schloesing Laboratories USA
| K Number | Device Name | ||
|---|---|---|---|
| K050436 | MS 9/5 HEMATOLOGY ANALYZER | Jul 27, 2005 | Substantially Equivalent |