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FDA 510(k)

ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL

K-Number: K964422 · 1996-11-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-11-25
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K964422. 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 ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL?

ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K964422.

When did ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL receive FDA 510(k) clearance?

ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL received FDA 510(k) clearance on 1996-11-25, under 510(k) number K964422.

Who is the listed applicant for ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL?

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

What is the FDA product code for ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL?

The FDA product code for ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL is DIF.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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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