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FDA 510(k)

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3

K-Number: K092645 · 2009-09-05

ApplicantFujirebio Diagnostics,Inc.
Decision Date2009-09-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2009-09-05 under 510(k) number K092645. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3?

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 2009-09-05. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K092645.

When did FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 receive FDA 510(k) clearance?

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 received FDA 510(k) clearance on 2009-09-05, under 510(k) number K092645.

Who is the listed applicant for FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3?

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

What is the FDA product code for FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3?

The FDA product code for FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 is JJX.

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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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