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FDA 510(k)

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

K-Number: K931666 · 1993-07-20

ApplicantR&D Systems, Inc.
Decision Date1993-07-20
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1993-07-20 under 510(k) number K931666. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY?

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY is a medical device that received FDA 510(k) clearance on 1993-07-20. The listed applicant is R&D Systems, Inc.. The 510(k) number is K931666.

When did QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY receive FDA 510(k) clearance?

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY received FDA 510(k) clearance on 1993-07-20, under 510(k) number K931666.

Who is the listed applicant for QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY?

The FDA product code for QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY is GGT.

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Related Devices (Code: GGT)

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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