OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT— 510(k) K121397
Substantially EquivalentSEKISUI Diagnostics, LLC
FDA 510(k) clearance K121397 for OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT, Substantially Equivalent on 2012-12-28. Applicant: SEKISUI Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- SEKISUI Diagnostics, LLC
- 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
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.