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FDA 510(k)

TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL

K-Number: K943422 · 1994-11-02

ApplicantUtak Lab, Inc.
Decision Date1994-11-02
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Utak Lab, Inc.. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K943422. 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 TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL?

TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Utak Lab, Inc.. The 510(k) number is K943422.

When did TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL receive FDA 510(k) clearance?

TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL received FDA 510(k) clearance on 1994-11-02, under 510(k) number K943422.

Who is the listed applicant for TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL?

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

What is the FDA product code for TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL?

The FDA product code for TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL is DIF.

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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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