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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus spp.

Oxoid Cefmetazole Susceptibility Test Disc

This document is an FDA 510(k) clearance letter for the "Oxoid Cefmetazole Antimicrobial Susceptibility Test Disc." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed acceptance criteria for the device's performance, nor does it describe a study proving the device meets acceptance criteria as requested in your prompt. The document is primarily a regulatory clearance notification.

Therefore, I cannot extract the information to complete your request based on the provided text. The document refers to the 'indications for use stated in the enclosure,' but the enclosure itself is not part of this text. Regulatory letters like this typically do not include the underlying performance study details.

To address your request, I would need access to the full 510(k) submission, which would include the performance data and the acceptance criteria agreed upon with the FDA.

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