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FDA 510(k)

GLUCOSE-HK TEST (GLU-HK) ITEM #65415

K-Number: K894483 · 1989-09-07

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-09-07
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE-HK TEST (GLU-HK) 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 1989-09-07 under 510(k) number K894483. 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 GLUCOSE-HK TEST (GLU-HK) ITEM #65415?

GLUCOSE-HK TEST (GLU-HK) ITEM #65415 is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K894483.

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

GLUCOSE-HK TEST (GLU-HK) ITEM #65415 received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894483.

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

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

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Related Devices (Code: CFR)

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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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