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FDA 510(k)

HI CHEM ELECTROLYTE REFERENCE REAGENT

K-Number: K925611 · 1993-02-23

ApplicantHichem Diagnostics
Decision Date1993-02-23
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM ELECTROLYTE REFERENCE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K925611. 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 HI CHEM ELECTROLYTE REFERENCE REAGENT?

HI CHEM ELECTROLYTE REFERENCE REAGENT is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Hichem Diagnostics. The 510(k) number is K925611.

When did HI CHEM ELECTROLYTE REFERENCE REAGENT receive FDA 510(k) clearance?

HI CHEM ELECTROLYTE REFERENCE REAGENT received FDA 510(k) clearance on 1993-02-23, under 510(k) number K925611.

Who is the listed applicant for HI CHEM ELECTROLYTE REFERENCE REAGENT?

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

What is the FDA product code for HI CHEM ELECTROLYTE REFERENCE REAGENT?

The FDA product code for HI CHEM ELECTROLYTE REFERENCE REAGENT is JGS.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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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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