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FDA 510(k)

EASYLYTE CALCIUM/CHLORIDE ANALYZER

K-Number: K963694 · 1996-11-27

ApplicantMedica Corp.
Decision Date1996-11-27
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYLYTE CALCIUM/CHLORIDE 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 1996-11-27 under 510(k) number K963694. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYLYTE CALCIUM/CHLORIDE ANALYZER?

EASYLYTE CALCIUM/CHLORIDE ANALYZER is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Medica Corp.. The 510(k) number is K963694.

When did EASYLYTE CALCIUM/CHLORIDE ANALYZER receive FDA 510(k) clearance?

EASYLYTE CALCIUM/CHLORIDE ANALYZER received FDA 510(k) clearance on 1996-11-27, under 510(k) number K963694.

Who is the listed applicant for EASYLYTE CALCIUM/CHLORIDE 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 CALCIUM/CHLORIDE ANALYZER?

The FDA product code for EASYLYTE CALCIUM/CHLORIDE ANALYZER is JFP.

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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: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl 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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