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FDA 510(k)

GLUCOSE-6-PHOSPHATE DEHYDROGENASE

K-Number: K823900 · 1983-02-07

ApplicantAlladin Diagnostic, Inc.
Decision Date1983-02-07
Product CodeKQE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLUCOSE-6-PHOSPHATE DEHYDROGENASE 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 1983-02-07 under 510(k) number K823900. The device is classified under product code KQE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE-6-PHOSPHATE DEHYDROGENASE?

GLUCOSE-6-PHOSPHATE DEHYDROGENASE is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Alladin Diagnostic, Inc.. The 510(k) number is K823900.

When did GLUCOSE-6-PHOSPHATE DEHYDROGENASE receive FDA 510(k) clearance?

GLUCOSE-6-PHOSPHATE DEHYDROGENASE received FDA 510(k) clearance on 1983-02-07, under 510(k) number K823900.

Who is the listed applicant for GLUCOSE-6-PHOSPHATE DEHYDROGENASE?

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 GLUCOSE-6-PHOSPHATE DEHYDROGENASE?

The FDA product code for GLUCOSE-6-PHOSPHATE DEHYDROGENASE is KQE.

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Other records listing Alladin Diagnostic, Inc. as applicant

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.

K844965LEUCINE AMINOPEPTIDASE REAGENT

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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