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FDA 510(k)

EPO-TRAC BY RADIOIMMUNOASSAY (RIA)

K-Number: K893393 · 1989-11-21

ApplicantIncstar Corp.
Decision Date1989-11-21
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EPO-TRAC BY 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 1989-11-21 under 510(k) number K893393. 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 BY RADIOIMMUNOASSAY (RIA)?

EPO-TRAC BY RADIOIMMUNOASSAY (RIA) is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Incstar Corp.. The 510(k) number is K893393.

When did EPO-TRAC BY RADIOIMMUNOASSAY (RIA) receive FDA 510(k) clearance?

EPO-TRAC BY RADIOIMMUNOASSAY (RIA) received FDA 510(k) clearance on 1989-11-21, under 510(k) number K893393.

Who is the listed applicant for EPO-TRAC BY 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 BY RADIOIMMUNOASSAY (RIA)?

The FDA product code for EPO-TRAC BY RADIOIMMUNOASSAY (RIA) is GGT.

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Other records listing Incstar Corp. 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)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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