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FDA 510(k)

DAU I, DAU II, DAU III AND DAU IV CONTROL URINE

K-Number: K893835 · 1989-07-25

ApplicantCiba Corning Diagnostics Corp.
Decision Date1989-07-25
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DAU I, DAU II, DAU III AND DAU IV CONTROL URINE is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893835. 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 DAU I, DAU II, DAU III AND DAU IV CONTROL URINE?

DAU I, DAU II, DAU III AND DAU IV CONTROL URINE is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K893835.

When did DAU I, DAU II, DAU III AND DAU IV CONTROL URINE receive FDA 510(k) clearance?

DAU I, DAU II, DAU III AND DAU IV CONTROL URINE received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893835.

Who is the listed applicant for DAU I, DAU II, DAU III AND DAU IV CONTROL URINE?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAU I, DAU II, DAU III AND DAU IV CONTROL URINE?

The FDA product code for DAU I, DAU II, DAU III AND DAU IV CONTROL URINE is DIF.

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Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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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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