FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAK-CHEX PLUS RETICS
K Number: K090137
·
Decision Mar 18, 2009
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
9
Applicant Total
33
Review Days
56
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Basic Information
- Device Name
- STAK-CHEX PLUS RETICS
- K Number
- K090137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck
- Date Received
- January 21, 2009
- Decision Date
- March 18, 2009
- Product Code
- GLQ
- 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 |
|---|---|---|---|
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | FDA class 2 | Hematology |
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STAK-CHEX PLUS RETICS
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