FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IND ONE STEP OCCULT BLOOD (FOB) TEST
K Number: K113506
·
Decision Dec 19, 2012
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
2
Review Days
387
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Basic Information
- Device Name
- IND ONE STEP OCCULT BLOOD (FOB) TEST
- K Number
- K113506
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ind Diagnostics, Inc.
- Date Received
- November 28, 2011
- Decision Date
- December 19, 2012
- 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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Other Clearances by Ind Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110889 | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) | Jun 20, 2011 | Substantially Equivalent |