FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPO-RIA
K Number: K910481
·
Decision Nov 29, 1991
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
19
Applicant Total
9
Review Days
296
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Basic Information
- Device Name
- EPO-RIA
- K Number
- K910481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7250
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ramco Laboratories, Inc.
- Date Received
- February 6, 1991
- Decision Date
- November 29, 1991
- Product Code
- GGT
- 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 |
|---|---|---|---|
| GGT | Assay, Erythropoietin | FDA class 2 | Hematology |
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| K Number | Device Name | ||
|---|---|---|---|
| K983107 | VFE | Oct 22, 1998 | Substantially Equivalent |
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| K861159 | SPECTRO VWF | May 1, 1986 | Substantially Equivalent |
| K831470 | PTH MR | Jun 22, 1983 | Substantially Equivalent |
| K823016 | CANDIDA DETECTION SYSTEM | Dec 28, 1982 | Substantially Equivalent |
| K812056 | SPECTRO FEIRITIN | Aug 12, 1981 | Substantially Equivalent |