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FDA 510(k)

DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE

K-Number: K831740 · 1983-07-06

ApplicantUtak Laboratories, Inc.
Decision Date1983-07-06
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE 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 1983-07-06 under 510(k) number K831740. 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 DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE?

DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE is a medical device that received FDA 510(k) clearance on 1983-07-06. The listed applicant is Utak Laboratories, Inc.. The 510(k) number is K831740.

When did DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE receive FDA 510(k) clearance?

DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE received FDA 510(k) clearance on 1983-07-06, under 510(k) number K831740.

Who is the listed applicant for DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE?

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 DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE?

The FDA product code for DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE 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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