FDA 510(k)

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS

K-Number: K936166 · 1994-07-13

Decision Date1994-07-13

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K936166. 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 CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS?

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K936166.

When did CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS receive FDA 510(k) clearance?

CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS received FDA 510(k) clearance on 1994-07-13, under 510(k) number K936166.

Who is the listed applicant for CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS?

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

What is the FDA product code for CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS?

The FDA product code for CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS is DIF.

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Other records listing Medical Analysis Systems, Inc. as applicant

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H K040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 K032826MAS PAR TDM K032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL K031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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.