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FDA 510(k)

HICHEM ISE ELECTROLYTE REFERENCE

K-Number: K992842 · 1999-11-26

ApplicantElan Holdings, Inc.
Decision Date1999-11-26
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ISE ELECTROLYTE REFERENCE is the device name listed in this FDA 510(k) record. The listed applicant is Elan Holdings, Inc.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K992842. 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 HICHEM ISE ELECTROLYTE REFERENCE?

HICHEM ISE ELECTROLYTE REFERENCE is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K992842.

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

HICHEM ISE ELECTROLYTE REFERENCE received FDA 510(k) clearance on 1999-11-26, under 510(k) number K992842.

Who is the listed applicant for HICHEM ISE ELECTROLYTE REFERENCE?

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

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

The FDA product code for HICHEM ISE ELECTROLYTE REFERENCE is 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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