DORIPENEM 10UG BBL SENSI-DISC— 510(k) K080998
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K080998 for DORIPENEM 10UG BBL SENSI-DISC, Substantially Equivalent on 2008-05-12. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
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Recalls naming K080998
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 K080998.
Data sourced from openFDA. This site is unofficial and independent of the FDA.