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FDA 510(k)

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS

K-Number: K860919 · 1986-04-11

ApplicantFisher Scientific Co., LLC
Decision Date1986-04-11
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K860919. 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 THERACHEM, TDC THERAPEUTIC DRUG CONTROLS?

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K860919.

When did THERACHEM, TDC THERAPEUTIC DRUG CONTROLS receive FDA 510(k) clearance?

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860919.

Who is the listed applicant for THERACHEM, TDC THERAPEUTIC DRUG CONTROLS?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERACHEM, TDC THERAPEUTIC DRUG CONTROLS?

The FDA product code for THERACHEM, TDC THERAPEUTIC DRUG CONTROLS is DIF.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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

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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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