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FDA 510(k)

MULTICHECK

K-Number: K952725 · 1996-02-20

ApplicantRadiometer America, Inc.
Decision Date1996-02-20
Product CodeGLY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MULTICHECK is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1996-02-20 under 510(k) number K952725. The device is classified under product code GLY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICHECK?

MULTICHECK is a medical device that received FDA 510(k) clearance on 1996-02-20. The listed applicant is Radiometer America, Inc.. The 510(k) number is K952725.

When did MULTICHECK receive FDA 510(k) clearance?

MULTICHECK received FDA 510(k) clearance on 1996-02-20, under 510(k) number K952725.

Who is the listed applicant for MULTICHECK?

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

What is the FDA product code for MULTICHECK?

The FDA product code for MULTICHECK is GLY.

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Other records listing Radiometer America, 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.

K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitK992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULEK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

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Related Devices (Code: GLY)

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.

K050014HEMONIR TMNir Diagnostics, Inc.K993104STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORNova Biomedical Corp.K955013NOVA CO-OXIMETER ANALYZERNova Biomedical Corp.K895466AVL MODEL 912 CO-OXYLITEAvl Scientific Corp.

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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