Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CEDIA DAU PROPOXYPHENE ASSAY

K-Number: K951133 · 1995-05-02

ApplicantMicrogenics Corp.
Decision Date1995-05-02
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU PROPOXYPHENE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K951133. 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 CEDIA DAU PROPOXYPHENE ASSAY?

CEDIA DAU PROPOXYPHENE ASSAY is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Microgenics Corp.. The 510(k) number is K951133.

When did CEDIA DAU PROPOXYPHENE ASSAY receive FDA 510(k) clearance?

CEDIA DAU PROPOXYPHENE ASSAY received FDA 510(k) clearance on 1995-05-02, under 510(k) number K951133.

Who is the listed applicant for CEDIA DAU PROPOXYPHENE ASSAY?

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

What is the FDA product code for CEDIA DAU PROPOXYPHENE ASSAY?

The FDA product code for CEDIA DAU PROPOXYPHENE ASSAY is JXN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Microgenics Corp. 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

View all 106 devices →

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.

↑