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FDA 510(k)

ERYTHROPOIETIN ENZYME IMMUNOASSAY

K-Number: K882686 · 1988-12-20

ApplicantAmgen, Inc.
Decision Date1988-12-20
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ERYTHROPOIETIN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Amgen, Inc.. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K882686. 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 ERYTHROPOIETIN ENZYME IMMUNOASSAY?

ERYTHROPOIETIN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is Amgen, Inc.. The 510(k) number is K882686.

When did ERYTHROPOIETIN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

ERYTHROPOIETIN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1988-12-20, under 510(k) number K882686.

Who is the listed applicant for ERYTHROPOIETIN ENZYME IMMUNOASSAY?

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 ERYTHROPOIETIN ENZYME IMMUNOASSAY?

The FDA product code for ERYTHROPOIETIN ENZYME IMMUNOASSAY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K894943CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

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

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