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FDA 510(k)

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3

K-Number: K844018 · 1984-11-27

ApplicantUnited Diagnostics, Inc.
Decision Date1984-11-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 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 1984-11-27 under 510(k) number K844018. 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 BRAND CO-OXIMETER CONTROLS 1,2 & 3?

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K844018.

When did GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 receive FDA 510(k) clearance?

GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844018.

Who is the listed applicant for GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3?

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 BRAND CO-OXIMETER CONTROLS 1,2 & 3?

The FDA product code for GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 is JJY.

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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 PLUSK862278GAS-TRAKK843986STAT-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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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