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FDA 510(k)

GAS-TRAK

K-Number: K862278 · 1986-08-04

ApplicantUnited Diagnostics, Inc.
Decision Date1986-08-04
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAS-TRAK is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K862278. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS-TRAK?

GAS-TRAK is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K862278.

When did GAS-TRAK receive FDA 510(k) clearance?

GAS-TRAK received FDA 510(k) clearance on 1986-08-04, under 510(k) number K862278.

Who is the listed applicant for GAS-TRAK?

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

What is the FDA product code for GAS-TRAK?

The FDA product code for GAS-TRAK is JJY.

Other records listing United Diagnostics, 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.

K884977GAS TRAK PLUSK844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3K843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3K831389STAT-TRAK LIQUID ELECTROLYTE CONTROLK831813CO-OXIMETER CONTROLK831814CALIBRATION STANDARD-HEMOGLOBIN

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Related Devices (Code: JJY)

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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