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FDA 510(k)

PROPOXPHENE EIA TEST

K-Number: K943414 · 1994-09-09

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-09-09
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROPOXPHENE 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 1994-09-09 under 510(k) number K943414. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPOXPHENE EIA TEST?

PROPOXPHENE EIA TEST is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K943414.

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

PROPOXPHENE EIA TEST received FDA 510(k) clearance on 1994-09-09, under 510(k) number K943414.

Who is the listed applicant for PROPOXPHENE 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 PROPOXPHENE EIA TEST?

The FDA product code for PROPOXPHENE EIA TEST is JXN.

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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: JXN)

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.

K122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDBranan Medical Corp.K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALMedica Corp.K043303ONLINE DAT PROPOXYPHENE PLUSRoche Diagnostics Corp.K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEACON Laboratories, Inc.K030835'RAPID ONE' - PROPOXYPHENE TESTAmerican Bio Medica Corp.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, 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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