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FDA 510(k)

TRICYCLIC ANTIDEPRESSANT II TX CONTROL

K-Number: K800889 · 1980-04-29

ApplicantUtak Laboratories, Inc.
Decision Date1980-04-29
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TRICYCLIC ANTIDEPRESSANT II TX CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Utak Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800889. 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 TRICYCLIC ANTIDEPRESSANT II TX CONTROL?

TRICYCLIC ANTIDEPRESSANT II TX CONTROL is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Utak Laboratories, Inc.. The 510(k) number is K800889.

When did TRICYCLIC ANTIDEPRESSANT II TX CONTROL receive FDA 510(k) clearance?

TRICYCLIC ANTIDEPRESSANT II TX CONTROL received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800889.

Who is the listed applicant for TRICYCLIC ANTIDEPRESSANT II TX CONTROL?

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

What is the FDA product code for TRICYCLIC ANTIDEPRESSANT II TX CONTROL?

The FDA product code for TRICYCLIC ANTIDEPRESSANT II TX CONTROL is DIF.

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Other records listing Utak Laboratories, 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.

K903061UTAK LABORATORIES TOXICOLOGY CONTROLK883147TRACE ELEMENTS SERUM TOXICOLOGY CONTROLK862418BENZODIAZEPINES TOXICOLOGY CONTROLK862419SERUM VANCOMYCIN TOXICOLOGY CONTROLK862421SERUM CLONAZEPAM TOXICOLOGY CONTROLK862420UTAK-STABBS TOXICOLOGY CONTROL

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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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