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FDA 510(k)

AC/AD LINEARITY VERIFIERS

K-Number: K982217 · 1998-07-02

ApplicantSc Calibrators & Controls, LLC
Decision Date1998-07-02
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AC/AD LINEARITY VERIFIERS is the device name listed in this FDA 510(k) record. The listed applicant is Sc Calibrators & Controls, LLC. It received FDA 510(k) clearance on 1998-07-02 under 510(k) number K982217. 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 AC/AD LINEARITY VERIFIERS?

AC/AD LINEARITY VERIFIERS is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Sc Calibrators & Controls, LLC. The 510(k) number is K982217.

When did AC/AD LINEARITY VERIFIERS receive FDA 510(k) clearance?

AC/AD LINEARITY VERIFIERS received FDA 510(k) clearance on 1998-07-02, under 510(k) number K982217.

Who is the listed applicant for AC/AD LINEARITY VERIFIERS?

The FDA 510(k) record lists Sc Calibrators & Controls, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AC/AD LINEARITY VERIFIERS?

The FDA product code for AC/AD LINEARITY VERIFIERS is DIF.

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Other records listing Sc Calibrators & Controls, 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.

K973791ABC CALIBRATION VERIFIERSK973790ABC LINEARITY VERIFIERS

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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