FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN REAGENT SET
K Number: K841057
·
Decision Mar 23, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
40
Review Days
11
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Basic Information
- Device Name
- HEMOGLOBIN REAGENT SET
- K Number
- K841057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties, Inc.
- Date Received
- March 12, 1984
- Decision Date
- March 23, 1984
- 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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|---|---|---|---|
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| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |