FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K Number: K903841
·
Decision Oct 22, 1990
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
45
Applicant Total
130
Review Days
62
Basic Information
- Device Name
- ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
- K Number
- K903841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7525
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ORGANON TEKNIKA CORP.
- Date Received
- August 21, 1990
- Decision Date
- October 22, 1990
- 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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