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FDA 510(k)

U-DOA CONTROLS

K-Number: K961724 · 1996-06-03

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1996-06-03
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

U-DOA CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1996-06-03 under 510(k) number K961724. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-DOA CONTROLS?

U-DOA CONTROLS is a medical device that received FDA 510(k) clearance on 1996-06-03. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K961724.

When did U-DOA CONTROLS receive FDA 510(k) clearance?

U-DOA CONTROLS received FDA 510(k) clearance on 1996-06-03, under 510(k) number K961724.

Who is the listed applicant for U-DOA CONTROLS?

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

What is the FDA product code for U-DOA CONTROLS?

The FDA product code for U-DOA CONTROLS is DIF.

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Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

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Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, Inc.

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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