FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FAT RED 7B STAIN SET
K Number: K792549
·
Decision Dec 18, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
27
Review Days
8
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Basic Information
- Device Name
- FAT RED 7B STAIN SET
- K Number
- K792549
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Electrophoresis Corp. of America
- Date Received
- December 10, 1979
- Decision Date
- December 18, 1979
- Product Code
- HYD
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| HYD | Fast Red Salt B | FDA class 1 | Hematology |
Other Clearances by Electrophoresis Corp. of America
| K Number | Device Name | ||
|---|---|---|---|
| K802396 | GENERAL PROCEDURE AGAROSE FILM | Nov 26, 1980 | Substantially Equivalent |
| K792548 | ALKALINE PHOSPHATASE MARKER | Jan 29, 1980 | Substantially Equivalent |
| K792547 | AGAROSE BARBITAL BUFFER | Jan 29, 1980 | Substantially Equivalent |
| K792551 | ALKALINE PHOSPHATASE REAGENT | Jan 29, 1980 | Substantially Equivalent |
| K792553 | AGAROSE BARBITAL-EDTA BUFFER | Jan 29, 1980 | Substantially Equivalent |
| K792574 | MOPSO BUFFER | Jan 21, 1980 | Substantially Equivalent |
| K792550 | PONCEAU S STAIN SET | Jan 16, 1980 | Substantially Equivalent |
| K792552 | AMIDO BLACK 10B STAIN | Dec 18, 1979 | Substantially Equivalent |
| K791656 | ENZYME STABILIZING REAGENT (ESR) | Sep 17, 1979 | Substantially Equivalent |
| K791655 | CPK ISOENZYME REAGENT | Sep 17, 1979 | Substantially Equivalent |