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FDA 510(k)

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

K-Number: K894943 · 1989-10-10

ApplicantAmgen, Inc.
Decision Date1989-10-10
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 is the device name listed in this FDA 510(k) record. The listed applicant is Amgen, Inc.. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K894943. 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 CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3?

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Amgen, Inc.. The 510(k) number is K894943.

When did CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 receive FDA 510(k) clearance?

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 received FDA 510(k) clearance on 1989-10-10, under 510(k) number K894943.

Who is the listed applicant for CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3?

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

What is the FDA product code for CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3?

The FDA product code for CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 is GGT.

Related Clinical Trials

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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Other records listing Amgen, 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.

K882686ERYTHROPOIETIN ENZYME IMMUNOASSAY

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.

K240182Access EPOBeckman Coulter, Inc.K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics LimitedK052223ACCESS EPO ASSAYBeckman Coulter, Inc.K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute Diagnostics

Official Source

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