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FDA 510(k)

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB

K-Number: K834294 · 1984-01-24

ApplicantEmd Chemicals, Inc.
Decision Date1984-01-24
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834294. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB?

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K834294.

When did ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB receive FDA 510(k) clearance?

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834294.

Who is the listed applicant for ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB?

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

What is the FDA product code for ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB?

The FDA product code for ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB is LCP.

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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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