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FDA 510(k)

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY

K-Number: K980737 · 1999-03-23

ApplicantNichols Institute Diagnostics
Decision Date1999-03-23
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1999-03-23 under 510(k) number K980737. 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 ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY?

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1999-03-23. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K980737.

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

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY received FDA 510(k) clearance on 1999-03-23, under 510(k) number K980737.

Who is the listed applicant for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY?

The FDA 510(k) record lists Nichols Institute Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY?

The FDA product code for ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY is GGT.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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.K952559ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute

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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