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FDA 510(k)

GENCHEM ELECTROLYTE BUFFER

K-Number: K040977 · 2004-12-27

ApplicantGenchem, Inc.
Decision Date2004-12-27
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENCHEM ELECTROLYTE BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K040977. 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 ELECTROLYTE BUFFER?

GENCHEM ELECTROLYTE BUFFER is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Genchem, Inc.. The 510(k) number is K040977.

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

GENCHEM ELECTROLYTE BUFFER received FDA 510(k) clearance on 2004-12-27, under 510(k) number K040977.

Who is the listed applicant for GENCHEM ELECTROLYTE BUFFER?

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 ELECTROLYTE BUFFER?

The FDA product code for GENCHEM ELECTROLYTE BUFFER 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-CAL3K040972CALCIUM, AZO DYE REAGENTK040973BUN REAGENTK040975GENCHEM CO2 ACID REAGENTK040974GLUCOSE OXIDASE, GLUCOSEK040976GENCHEM CREATININE REAGENT

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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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