FDA 510(k)

THERACHEM ANTI CONVULSANTA THEOPHYLLINE

K-Number: K810504 · 1981-03-11

Decision Date1981-03-11

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

THERACHEM ANTI CONVULSANTA THEOPHYLLINE 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 1981-03-11 under 510(k) number K810504. 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 ANTI CONVULSANTA THEOPHYLLINE?

THERACHEM ANTI CONVULSANTA THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K810504.

When did THERACHEM ANTI CONVULSANTA THEOPHYLLINE receive FDA 510(k) clearance?

THERACHEM ANTI CONVULSANTA THEOPHYLLINE received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810504.

Who is the listed applicant for THERACHEM ANTI CONVULSANTA THEOPHYLLINE?

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 ANTI CONVULSANTA THEOPHYLLINE?

The FDA product code for THERACHEM ANTI CONVULSANTA THEOPHYLLINE is DIF.

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Other records listing Fisher Scientific Co., LLC as applicant

K930415MICROHEMATOCRIT ROTOR K915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGE K915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE K890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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Related Devices (Code: DIF)

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 Laboratories K120504LIQUICHEK 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.