FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
hema-screen SPECIFIC Gold
K Number: K171484
·
Decision Jun 14, 2017
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- hema-screen SPECIFIC Gold
- K Number
- K171484
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunostics Inc.,
- Date Received
- May 22, 2017
- Decision Date
- June 14, 2017
- 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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| K102664 | HEMA SCREEN ER | Jan 28, 2011 | Substantially Equivalent |
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