GenePOC CDiff— 510(k) K172569
Substantially EquivalentGenepoc, Inc.
FDA 510(k) clearance K172569 for GenePOC CDiff, Substantially Equivalent on 2017-11-22. Applicant: Genepoc, Inc.. Device class: 2.
Clearance details
- Applicant
- Genepoc, Inc.
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec, CA
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More clearances from Genepoc, Inc.
view allRecalls naming K172569
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172569.
Data sourced from openFDA. This site is unofficial and independent of the FDA.