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FDA 510(k)

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620

K-Number: K071644 · 2007-09-12

ApplicantRoche Diagnostics Corp.
Decision Date2007-09-12
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2007-09-12 under 510(k) number K071644. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620?

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 is a medical device that received FDA 510(k) clearance on 2007-09-12. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K071644.

When did ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 receive FDA 510(k) clearance?

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 received FDA 510(k) clearance on 2007-09-12, under 510(k) number K071644.

Who is the listed applicant for ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620?

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

What is the FDA product code for ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620?

The FDA product code for ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 is DLZ.

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Related Devices (Code: DLZ)

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K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.K000012IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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