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FDA 510(k)

MIRCOLINE SCREEN FOR COCAINE

K-Number: K911652 · 1991-05-15

ApplicantDrug Screening Systems, Inc.
Decision Date1991-05-15
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MIRCOLINE SCREEN FOR COCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Drug Screening Systems, Inc.. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K911652. 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 MIRCOLINE SCREEN FOR COCAINE?

MIRCOLINE SCREEN FOR COCAINE is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Drug Screening Systems, Inc.. The 510(k) number is K911652.

When did MIRCOLINE SCREEN FOR COCAINE receive FDA 510(k) clearance?

MIRCOLINE SCREEN FOR COCAINE received FDA 510(k) clearance on 1991-05-15, under 510(k) number K911652.

Who is the listed applicant for MIRCOLINE SCREEN FOR COCAINE?

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

What is the FDA product code for MIRCOLINE SCREEN FOR COCAINE?

The FDA product code for MIRCOLINE SCREEN FOR COCAINE is DIO.

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Other records listing Drug Screening Systems, 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.

K945829MICROLINE SCREEN FOR BENZODIAZEPINEK935052MICROLINE SCREEN FOR AMPHETAMINEK933480MICROLINE SCREEN FOR BARBITURATESK921651MICROLINE SCREEN FOR PHENCYCLIDINEK914915MICROLINE SCREEN FOR CANNABINOIDK910525MICROLINE SCREEN FOR METHAMPHETAMINE

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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

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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