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FDA 510(k)

EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)

K-Number: K902639 · 1990-08-22

ApplicantIncstar Corp.
Decision Date1990-08-22
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K902639. 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 EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)?

EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Incstar Corp.. The 510(k) number is K902639.

When did EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) receive FDA 510(k) clearance?

EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) received FDA 510(k) clearance on 1990-08-22, under 510(k) number K902639.

Who is the listed applicant for EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)?

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

What is the FDA product code for EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)?

The FDA product code for EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) is GGT.

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Other records listing Incstar Corp. as applicant

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K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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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

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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