FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECINORM HB
K Number: K852136
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
14
Applicant Total
340
Review Days
50
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Basic Information
- Device Name
- PRECINORM HB
- K Number
- K852136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- May 16, 1985
- Decision Date
- July 5, 1985
- Product Code
- GGM
- 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 |
|---|---|---|---|
| GGM | Control, Hemoglobin | FDA class 2 | Hematology |
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