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FDA 510(k)

ACCUREX GLUCOSE TEST STRIP

K-Number: K052207 · 2006-03-09

ApplicantIncline Medical, LLC
Decision Date2006-03-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUREX GLUCOSE TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Incline Medical, LLC. It received FDA 510(k) clearance on 2006-03-09 under 510(k) number K052207. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUREX GLUCOSE TEST STRIP?

ACCUREX GLUCOSE TEST STRIP is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Incline Medical, LLC. The 510(k) number is K052207.

When did ACCUREX GLUCOSE TEST STRIP receive FDA 510(k) clearance?

ACCUREX GLUCOSE TEST STRIP received FDA 510(k) clearance on 2006-03-09, under 510(k) number K052207.

Who is the listed applicant for ACCUREX GLUCOSE TEST STRIP?

The FDA 510(k) record lists Incline Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUREX GLUCOSE TEST STRIP?

The FDA product code for ACCUREX GLUCOSE TEST STRIP is CGA.

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Related Devices (Code: CGA)

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.

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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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