FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTROL-ABNORMAL
K Number: K760596
·
Decision Oct 8, 1976
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
340
Review Days
31
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Basic Information
- Device Name
- BIOTROL-ABNORMAL
- K Number
- K760596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- September 7, 1976
- Decision Date
- October 8, 1976
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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