FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K Number: K853462
·
Decision Aug 29, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
149
Review Days
10
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Basic Information
- Device Name
- COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
- K Number
- K853462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- August 19, 1985
- Decision Date
- August 29, 1985
- 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 American Dade
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|---|---|---|---|
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| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
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