FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINISTAT HEMOGLOBIN REAGENT TEST
K Number: K885227
·
Decision Feb 24, 1989
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
38
Applicant Total
145
Review Days
66
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Basic Information
- Device Name
- CLINISTAT HEMOGLOBIN REAGENT TEST
- K Number
- K885227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- December 20, 1988
- Decision Date
- February 24, 1989
- Product Code
- KHG
- 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 |
|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | FDA class 2 | Hematology |
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