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FDA 510(k)

ERYTHROPOIETIN EIA

K-Number: K833957 · 1984-03-23

ApplicantJcl Clinical Research Corp.
Decision Date1984-03-23
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ERYTHROPOIETIN EIA is the device name listed in this FDA 510(k) record. The listed applicant is Jcl Clinical Research Corp.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K833957. 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 EIA?

ERYTHROPOIETIN EIA is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Jcl Clinical Research Corp.. The 510(k) number is K833957.

When did ERYTHROPOIETIN EIA receive FDA 510(k) clearance?

ERYTHROPOIETIN EIA received FDA 510(k) clearance on 1984-03-23, under 510(k) number K833957.

Who is the listed applicant for ERYTHROPOIETIN EIA?

The FDA 510(k) record lists Jcl Clinical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERYTHROPOIETIN EIA?

The FDA product code for ERYTHROPOIETIN EIA 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.

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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