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FDA 510(k)

PRIMIDONE EIA TEST

K-Number: K960526 · 1996-03-18

ApplicantDiagnostic Reagents, Inc.
Decision Date1996-03-18
Product CodeDJP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PRIMIDONE EIA TEST 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 1996-03-18 under 510(k) number K960526. The device is classified under product code DJP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMIDONE EIA TEST?

PRIMIDONE EIA TEST is a medical device that received FDA 510(k) clearance on 1996-03-18. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K960526.

When did PRIMIDONE EIA TEST receive FDA 510(k) clearance?

PRIMIDONE EIA TEST received FDA 510(k) clearance on 1996-03-18, under 510(k) number K960526.

Who is the listed applicant for PRIMIDONE EIA TEST?

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 PRIMIDONE EIA TEST?

The FDA product code for PRIMIDONE EIA TEST is DJP.

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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: DJP)

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.

K913866URINE AMPHETAMINE DIRECT RIA KIT (I-125)Immunalysis CorporationK912755ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINERoche Diagnostic Systems, Inc.K882228REVISED DOUBLE ANTIBODY AMPHETAMINEDiagnostic Products Corp.K881817ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINESRoche Diagnostic Systems, Inc.K854009ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SPRoche Diagnostic Systems, Inc.K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEHoffmann-La Roche, Inc.

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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