FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMSTRIP L
K Number: K811189
·
Decision Jul 27, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
21
Review Days
89
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Basic Information
- Device Name
- CHEMSTRIP L
- K Number
- K811189
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.7660
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- April 29, 1981
- Decision Date
- July 27, 1981
- Product Code
- GHD
- 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 |
|---|---|---|---|
| GHD | Test, Leukocyte Alkaline Phosphatase | FDA class 1 | Hematology |
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| K870052 | INFUMIX MIXING CONTAINER | Feb 27, 1987 | Substantially Equivalent |
| K822716 | UNIVERSAL CENTRIFUGE | Sep 30, 1982 | Substantially Equivalent |
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