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)

LIVESURE MORPHINE SCREEN TEST

K-Number: K011011 · 2001-04-13

ApplicantPan Probe Biotech, Inc.
Decision Date2001-04-13
Product CodeDOE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIVESURE MORPHINE SCREEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pan Probe Biotech, Inc.. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K011011. The device is classified under product code DOE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIVESURE MORPHINE SCREEN TEST?

LIVESURE MORPHINE SCREEN TEST is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Pan Probe Biotech, Inc.. The 510(k) number is K011011.

When did LIVESURE MORPHINE SCREEN TEST receive FDA 510(k) clearance?

LIVESURE MORPHINE SCREEN TEST received FDA 510(k) clearance on 2001-04-13, under 510(k) number K011011.

Who is the listed applicant for LIVESURE MORPHINE SCREEN TEST?

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

What is the FDA product code for LIVESURE MORPHINE SCREEN TEST?

The FDA product code for LIVESURE MORPHINE SCREEN TEST is DOE.

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 Pan Probe Biotech, 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.

K020968LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARDK013796LIVESURE METHADONE SCREEN TESTSK012107LIVESURE PHENECYCLINE (PCP) SCREEN TESTSK012133LIVESURE BARBITURATES SCREEN TESTK012131LIVESURE BENZODIAZEPINES SCREEN TESTSK011609LIVESURE AMPHETAMINE SCREEN TEST

View all 10 devices →

Related Devices (Code: DOE)

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.

K010080INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TESTAlfa Scientific Designs, Inc.K010079INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTAlfa Scientific Designs, Inc.K002418BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133DBranan Medical CorporationK951319ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATIONRoche Diagnostic Systems, Inc.K935055ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)Roche Diagnostic Systems, Inc.K933572URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)Immunalysis Corporation

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.

↑