FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K Number: K042251
·
Decision Sep 17, 2004
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
46
Review Days
28
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Basic Information
- Device Name
- BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K Number
- K042251
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- August 20, 2004
- Decision Date
- September 17, 2004
- 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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