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FDA 510(k)

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

K-Number: K930985 · 1993-04-27

ApplicantU.S. Drug Testing, Inc.
Decision Date1993-04-27
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Drug Testing, Inc.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K930985. 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 USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100?

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is U.S. Drug Testing, Inc.. The 510(k) number is K930985.

When did USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 receive FDA 510(k) clearance?

USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 received FDA 510(k) clearance on 1993-04-27, under 510(k) number K930985.

Who is the listed applicant for USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100?

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

What is the FDA product code for USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100?

The FDA product code for USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 is DIO.

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Other records listing U.S. Drug Testing, 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.

K940912USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500K935629USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400K934693AMPHETAMINE TEST SYSTEMK932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200K931227USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000

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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