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FDA 510(k)

LEUCINE AMINOPEPTIDASE REAGENT

K-Number: K844965 · 1985-03-05

ApplicantAlladin Diagnostic, Inc.
Decision Date1985-03-05
Product CodeJGG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEUCINE AMINOPEPTIDASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alladin Diagnostic, Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K844965. The device is classified under product code JGG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEUCINE AMINOPEPTIDASE REAGENT?

LEUCINE AMINOPEPTIDASE REAGENT is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Alladin Diagnostic, Inc.. The 510(k) number is K844965.

When did LEUCINE AMINOPEPTIDASE REAGENT receive FDA 510(k) clearance?

LEUCINE AMINOPEPTIDASE REAGENT received FDA 510(k) clearance on 1985-03-05, under 510(k) number K844965.

Who is the listed applicant for LEUCINE AMINOPEPTIDASE REAGENT?

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

What is the FDA product code for LEUCINE AMINOPEPTIDASE REAGENT?

The FDA product code for LEUCINE AMINOPEPTIDASE REAGENT is JGG.

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Other records listing Alladin Diagnostic, Inc. as applicant

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Related Devices (Code: JGG)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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