hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test— 510(k) K163554
Substantially EquivalentImmunostics Inc.,
FDA 510(k) clearance K163554 for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test, Substantially Equivalent on 2017-01-17. Applicant: Immunostics Inc.,. Device class: 2.
Clearance details
- Applicant
- Immunostics Inc.,
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ocean, NJ, US
Recent devices under product code KHE
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