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FDA 510(k)

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6

K-Number: K964278 · 1996-11-22

ApplicantClinical Controls, Inc.
Decision Date1996-11-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Controls, Inc.. It received FDA 510(k) clearance on 1996-11-22 under 510(k) number K964278. 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 WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6?

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 is a medical device that received FDA 510(k) clearance on 1996-11-22. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K964278.

When did WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 receive FDA 510(k) clearance?

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 received FDA 510(k) clearance on 1996-11-22, under 510(k) number K964278.

Who is the listed applicant for WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6?

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

What is the FDA product code for WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6?

The FDA product code for WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 is JJX.

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Related Devices (Code: 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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