FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRO FEIRITIN
K Number: K812056
·
Decision Aug 12, 1981
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
9
Review Days
22
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Basic Information
- Device Name
- SPECTRO FEIRITIN
- K Number
- K812056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Ramco Laboratories, Inc.
- Date Received
- July 21, 1981
- Decision Date
- August 12, 1981
- Product Code
- DBF
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Ramco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983107 | VFE | Oct 22, 1998 | Substantially Equivalent |
| K981208 | TFR | Oct 21, 1998 | Substantially Equivalent |
| K910481 | EPO-RIA | Nov 29, 1991 | Substantially Equivalent |
| K872941 | SPECTRO C | Sep 4, 1987 | Substantially Equivalent |
| K864701 | VWF IMMUNOBLOT | Mar 30, 1987 | Substantially Equivalent |
| 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 |