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FDA 510(k)

FDTX GLUCOSE CONTROL SOLUTION

K-Number: K081915 · 2008-08-08

ApplicantFujirebio Diagnostics Texas, Inc.
Decision Date2008-08-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FDTX GLUCOSE CONTROL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics Texas, Inc.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081915. 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 FDTX GLUCOSE CONTROL SOLUTION?

FDTX GLUCOSE CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Fujirebio Diagnostics Texas, Inc.. The 510(k) number is K081915.

When did FDTX GLUCOSE CONTROL SOLUTION receive FDA 510(k) clearance?

FDTX GLUCOSE CONTROL SOLUTION received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081915.

Who is the listed applicant for FDTX GLUCOSE CONTROL SOLUTION?

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

What is the FDA product code for FDTX GLUCOSE CONTROL SOLUTION?

The FDA product code for FDTX GLUCOSE CONTROL SOLUTION is JJX.

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Other records listing Fujirebio Diagnostics Texas, Inc. 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.

K080273AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION

Related Devices (Code: JJX)

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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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