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FDA 510(k)

CO-OXIMETER CONTROL

K-Number: K831813 · 1983-07-28

ApplicantUnited Diagnostics, Inc.
Decision Date1983-07-28
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CO-OXIMETER CONTROL 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 1983-07-28 under 510(k) number K831813. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO-OXIMETER CONTROL?

CO-OXIMETER CONTROL is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K831813.

When did CO-OXIMETER CONTROL receive FDA 510(k) clearance?

CO-OXIMETER CONTROL received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831813.

Who is the listed applicant for CO-OXIMETER CONTROL?

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 CO-OXIMETER CONTROL?

The FDA product code for CO-OXIMETER CONTROL is KHG.

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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 & 3K844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3K831389STAT-TRAK LIQUID ELECTROLYTE CONTROLK831814CALIBRATION STANDARD-HEMOGLOBIN

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Related Devices (Code: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLC

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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