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FDA 510(k)

GAS TRAK CONNECT BLOOD GAS CONTROL

K-Number: K914099 · 1991-12-18

ApplicantBiochemical Sciences, Inc.
Decision Date1991-12-18
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAS TRAK CONNECT BLOOD GAS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Sciences, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914099. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS TRAK CONNECT BLOOD GAS CONTROL?

GAS TRAK CONNECT BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Biochemical Sciences, Inc.. The 510(k) number is K914099.

When did GAS TRAK CONNECT BLOOD GAS CONTROL receive FDA 510(k) clearance?

GAS TRAK CONNECT BLOOD GAS CONTROL received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914099.

Who is the listed applicant for GAS TRAK CONNECT BLOOD GAS CONTROL?

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

What is the FDA product code for GAS TRAK CONNECT BLOOD GAS CONTROL?

The FDA product code for GAS TRAK CONNECT BLOOD GAS CONTROL is JPK.

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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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