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FDA 510(k)

COMA COCAINE METABOLITE ASSAY (EIA)

K-Number: K895043 · 1989-11-08

ApplicantSerex, Inc.
Decision Date1989-11-08
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COMA COCAINE METABOLITE ASSAY (EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Serex, Inc.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K895043. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMA COCAINE METABOLITE ASSAY (EIA)?

COMA COCAINE METABOLITE ASSAY (EIA) is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Serex, Inc.. The 510(k) number is K895043.

When did COMA COCAINE METABOLITE ASSAY (EIA) receive FDA 510(k) clearance?

COMA COCAINE METABOLITE ASSAY (EIA) received FDA 510(k) clearance on 1989-11-08, under 510(k) number K895043.

Who is the listed applicant for COMA COCAINE METABOLITE ASSAY (EIA)?

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

What is the FDA product code for COMA COCAINE METABOLITE ASSAY (EIA)?

The FDA product code for COMA COCAINE METABOLITE ASSAY (EIA) is DIO.

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 Serex, 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.

K923314AUTOMATES COMA PLUS COCAINE METABOLITE ASSAYK921834AUTOMATES COMA COCAINE METABOLITE ASSAYK901333BETA-2 MICROGLOBULIN EIAK890694BETA-2 MICROGLOBULIN EIA

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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