FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K Number: K100817
·
Decision Jul 1, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
72
Review Days
104
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Basic Information
- Device Name
- BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
- K Number
- K100817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- March 19, 2010
- Decision Date
- July 1, 2010
- Product Code
- KHE
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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