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FDA 510(k)

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE

K-Number: K992859 · 2000-01-10

ApplicantRadiometer America, Inc.
Decision Date2000-01-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE 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 2000-01-10 under 510(k) number K992859. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE?

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE is a medical device that received FDA 510(k) clearance on 2000-01-10. The listed applicant is Radiometer America, Inc.. The 510(k) number is K992859.

When did ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE receive FDA 510(k) clearance?

ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE received FDA 510(k) clearance on 2000-01-10, under 510(k) number K992859.

Who is the listed applicant for ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE?

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 ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE?

The FDA product code for ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE is CHL.

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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 KitK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760K974818ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM

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Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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