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FDA 510(k)

EML105 ELECTROLYTE METABOLITE ANALYZER

K-Number: K962334 · 1996-10-24

ApplicantRadiometer America, Inc.
Decision Date1996-10-24
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EML105 ELECTROLYTE METABOLITE ANALYZER 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 1996-10-24 under 510(k) number K962334. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EML105 ELECTROLYTE METABOLITE ANALYZER?

EML105 ELECTROLYTE METABOLITE ANALYZER is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Radiometer America, Inc.. The 510(k) number is K962334.

When did EML105 ELECTROLYTE METABOLITE ANALYZER receive FDA 510(k) clearance?

EML105 ELECTROLYTE METABOLITE ANALYZER received FDA 510(k) clearance on 1996-10-24, under 510(k) number K962334.

Who is the listed applicant for EML105 ELECTROLYTE METABOLITE ANALYZER?

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 EML105 ELECTROLYTE METABOLITE ANALYZER?

The FDA product code for EML105 ELECTROLYTE METABOLITE ANALYZER is JGS.

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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: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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