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FDA 510(k)

PHENOBARBITAL ENZYME IMMUNOASSAY

K-Number: K946210 · 1995-02-10

ApplicantDiagnostic Reagents, Inc.
Decision Date1995-02-10
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENOBARBITAL ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K946210. 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 PHENOBARBITAL ENZYME IMMUNOASSAY?

PHENOBARBITAL ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K946210.

When did PHENOBARBITAL ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

PHENOBARBITAL ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1995-02-10, under 510(k) number K946210.

Who is the listed applicant for PHENOBARBITAL ENZYME IMMUNOASSAY?

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

What is the FDA product code for PHENOBARBITAL ENZYME IMMUNOASSAY?

The FDA product code for PHENOBARBITAL ENZYME IMMUNOASSAY is DLZ.

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Other records listing Diagnostic Reagents, Inc. 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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Related Devices (Code: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.

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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