FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K Number: K853239
·
Decision Nov 5, 1985
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
45
Applicant Total
4
Review Days
96
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Basic Information
- Device Name
- HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
- K Number
- K853239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7525
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Haemachem, Inc.
- Date Received
- August 1, 1985
- Decision Date
- November 5, 1985
- Product Code
- KFF
- 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 |
|---|---|---|---|
| KFF | Assay, Heparin | FDA class 2 | Hematology |
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