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FDA 510(k)

ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32

K-Number: K913764 · 1991-11-05

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-11-05
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K913764. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32?

ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K913764.

When did ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 receive FDA 510(k) clearance?

ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 received FDA 510(k) clearance on 1991-11-05, under 510(k) number K913764.

Who is the listed applicant for ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32?

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

What is the FDA product code for ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32?

The FDA product code for ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 is JGJ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JGJ)

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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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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