FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VWF IMMUNOBLOT
K Number: K864701
·
Decision Mar 30, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
9
Review Days
118
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Basic Information
- Device Name
- VWF IMMUNOBLOT
- K Number
- K864701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ramco Laboratories, Inc.
- Date Received
- December 2, 1986
- Decision Date
- March 30, 1987
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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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 |
| 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 |