ETEST CEFTAROLINE— 510(k) K121002

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2012-04-02

Decision date

2012-10-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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• Z-0230-2015 — Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.Class III·Terminated·Biomerieux·20141016
• Z-0231-2015 — Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.Class III·Terminated·Biomerieux·20141016
• Z-0232-2015 — Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.Class III·Terminated·Biomerieux·20141016
• Z-0233-2015 — Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.Class III·Terminated·Biomerieux·20141016
• Z-0234-2015 — Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.Class III·Terminated·Biomerieux·20141016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121002.