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FDA 510(k)

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415

K-Number: K924572 · 1992-11-25

ApplicantEm Diagnostic Systems, Inc.
Decision Date1992-11-25
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 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 1992-11-25 under 510(k) number K924572. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415?

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K924572.

When did EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 receive FDA 510(k) clearance?

EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 received FDA 510(k) clearance on 1992-11-25, under 510(k) number K924572.

Who is the listed applicant for EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415?

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 EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415?

The FDA product code for EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 is CFR.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CFR)

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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