MEROPENEM, 10 MCG, SENSI-DISC— 510(k) K963845
Substantially EquivalentBecton Dickinson Microbiology Systems
FDA 510(k) clearance K963845 for MEROPENEM, 10 MCG, SENSI-DISC, Substantially Equivalent on 1996-10-25. Applicant: Becton Dickinson Microbiology Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Microbiology Systems
- 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
- Cockeysville, MD, US
Recent devices under product code JTN
view allMore clearances from Becton Dickinson Microbiology Systems
view all- K993577 — CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
- K984631 — BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- K981517 — CEFDINIR, 5 UG, SENSI-DISC
- K980683 — TROVAFLOXACIN 10G, SENSI-DISC
- K974578 — GREPAFLOXACIN, 5 MG, SENSI-DISC
Recalls naming K963845
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 K963845.
Data sourced from openFDA. This site is unofficial and independent of the FDA.