FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN REAGENT
K Number: K831618
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- HEMOGLOBIN REAGENT
- K Number
- K831618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Diagnostics
- Date Received
- May 19, 1983
- Decision Date
- June 16, 1983
- Product Code
- GKR
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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