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FDA 510(k)

ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE

K-Number: K043529 · 2005-04-08

ApplicantRoche Diagnostics Corp.
Decision Date2005-04-08
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE 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 2005-04-08 under 510(k) number K043529. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE?

ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-04-08. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043529.

When did ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE receive FDA 510(k) clearance?

ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE received FDA 510(k) clearance on 2005-04-08, under 510(k) number K043529.

Who is the listed applicant for ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE?

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 ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE?

The FDA product code for ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE is NDC.

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Other records listing Roche Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: NDC)

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Official Source

View on FDA Database →

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

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