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FDA 510(k)

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER

K-Number: K002855 · 2000-10-12

ApplicantBiocare Corp.
Decision Date2000-10-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Corp.. It received FDA 510(k) clearance on 2000-10-12 under 510(k) number K002855. 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 BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER?

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 2000-10-12. The listed applicant is Biocare Corp.. The 510(k) number is K002855.

When did BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER receive FDA 510(k) clearance?

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER received FDA 510(k) clearance on 2000-10-12, under 510(k) number K002855.

Who is the listed applicant for BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER?

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

What is the FDA product code for BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER?

The FDA product code for BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER is JGS.

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Other records listing Biocare 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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