DeviceClearance

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)— 510(k) K112586

Substantially Equivalent

Becton, Dickinson and Company (BD)

FDA 510(k) clearance K112586 for CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM), Substantially Equivalent on 2011-10-18. Applicant: Becton, Dickinson and Company (BD). Device class: 2.

Clearance details

Applicant
Becton, Dickinson and Company (BD)
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
Download summary PDFView on FDA.gov ↗

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Recalls naming K112586

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112586.

Data sourced from openFDA. This site is unofficial and independent of the FDA.