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FDA 510(k)

EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER

K-Number: K963763 · 1996-11-29

ApplicantMedica Corp.
Decision Date1996-11-29
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K963763. 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 EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER?

EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Medica Corp.. The 510(k) number is K963763.

When did EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER receive FDA 510(k) clearance?

EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER received FDA 510(k) clearance on 1996-11-29, under 510(k) number K963763.

Who is the listed applicant for EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER?

The FDA 510(k) record lists Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER?

The FDA product code for EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER is JGS.

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Other records listing Medica Corp. 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.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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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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