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FDA 510(k)

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19

K-Number: K964771 · 1997-02-04

ApplicantDyna-Tek Industries
Decision Date1997-02-04
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 is the device name listed in this FDA 510(k) record. The listed applicant is Dyna-Tek Industries. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964771. 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 DE-TOX CONTROL 1 AND DE-TOX CONTROL 19?

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Dyna-Tek Industries. The 510(k) number is K964771.

When did DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 receive FDA 510(k) clearance?

DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964771.

Who is the listed applicant for DE-TOX CONTROL 1 AND DE-TOX CONTROL 19?

The FDA 510(k) record lists Dyna-Tek Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DE-TOX CONTROL 1 AND DE-TOX CONTROL 19?

The FDA product code for DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 is DIF.

Related Clinical Trials

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Other records listing Dyna-Tek Industries 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.

K904326DE-TOX TUBES A AND DE-TOX TUBES B

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

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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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