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FDA 510(k)

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM

K-Number: K130138 · 2013-03-15

ApplicantRoche Diagnostics Corp.
Decision Date2013-03-15
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2013-03-15 under 510(k) number K130138. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM?

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-15. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K130138.

When did SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM receive FDA 510(k) clearance?

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM received FDA 510(k) clearance on 2013-03-15, under 510(k) number K130138.

Who is the listed applicant for SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM?

The FDA product code for SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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