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FDA 510(k)

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

K-Number: K923314 · 1992-08-24

ApplicantSerex, Inc.
Decision Date1992-08-24
Product CodeJXO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serex, Inc.. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K923314. The device is classified under product code JXO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY?

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Serex, Inc.. The 510(k) number is K923314.

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

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY received FDA 510(k) clearance on 1992-08-24, under 510(k) number K923314.

Who is the listed applicant for AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY?

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 AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY?

The FDA product code for AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY is JXO.

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.

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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.

K921834AUTOMATES COMA COCAINE METABOLITE ASSAYK901333BETA-2 MICROGLOBULIN EIAK895043COMA COCAINE METABOLITE ASSAY (EIA)K890694BETA-2 MICROGLOBULIN EIA

Related Devices (Code: JXO)

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.

K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics CorporationK111925PSYCHEMEDICS COCAINE EIAPsychemedics Corp.K921140STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIASolarcare Technologies Corp,Inc.K915785STC DIAGNOSTICS BENZOYLECGONINE EIASolarcare Technologies Corp,Inc.K913737IL TEST(TM) COCAINEInstrumentation Laboratory CO

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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