FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBRO-TEC TEST KIT
K Number: K791358
·
Decision Sep 4, 1979
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
41
Review Days
42
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Basic Information
- Device Name
- FIBRO-TEC TEST KIT
- K Number
- K791358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- July 24, 1979
- Decision Date
- September 4, 1979
- Product Code
- GHH
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
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Other Clearances by Calbiochem-Behring Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K830214 | AFT SYSTEM III | Mar 9, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |