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FDA 510(k)

GENCHEM ISE ELECTROLYTE REFERENCE

K-Number: K040971 · 2004-12-22

ApplicantGenchem, Inc.
Decision Date2004-12-22
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENCHEM ISE ELECTROLYTE REFERENCE is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K040971. 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 GENCHEM ISE ELECTROLYTE REFERENCE?

GENCHEM ISE ELECTROLYTE REFERENCE is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Genchem, Inc.. The 510(k) number is K040971.

When did GENCHEM ISE ELECTROLYTE REFERENCE receive FDA 510(k) clearance?

GENCHEM ISE ELECTROLYTE REFERENCE received FDA 510(k) clearance on 2004-12-22, under 510(k) number K040971.

Who is the listed applicant for GENCHEM ISE ELECTROLYTE REFERENCE?

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

What is the FDA product code for GENCHEM ISE ELECTROLYTE REFERENCE?

The FDA product code for GENCHEM ISE ELECTROLYTE REFERENCE is JGS.

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Other records listing Genchem, 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.

K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3K040977GENCHEM ELECTROLYTE BUFFERK040972CALCIUM, AZO DYE REAGENTK040975GENCHEM CO2 ACID REAGENTK040976GENCHEM CREATININE REAGENTK040974GLUCOSE OXIDASE, GLUCOSE

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Related Devices (Code: JGS)

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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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