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FDA 510(k)

MICROMEDIC MORPHINE RIA KIT

K-Number: K881102 · 1988-06-24

ApplicantIcn Micromedic Systems
Decision Date1988-06-24
Product CodeDOE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC MORPHINE RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Icn Micromedic Systems. It received FDA 510(k) clearance on 1988-06-24 under 510(k) number K881102. 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 MICROMEDIC MORPHINE RIA KIT?

MICROMEDIC MORPHINE RIA KIT is a medical device that received FDA 510(k) clearance on 1988-06-24. The listed applicant is Icn Micromedic Systems. The 510(k) number is K881102.

When did MICROMEDIC MORPHINE RIA KIT receive FDA 510(k) clearance?

MICROMEDIC MORPHINE RIA KIT received FDA 510(k) clearance on 1988-06-24, under 510(k) number K881102.

Who is the listed applicant for MICROMEDIC MORPHINE RIA KIT?

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

What is the FDA product code for MICROMEDIC MORPHINE RIA KIT?

The FDA product code for MICROMEDIC MORPHINE RIA KIT 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 Icn Micromedic Systems 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.

K884269SAMPLE IDENTIFICATION STATION MODEL 38010K883746MICROMEDIC FERRITIN IRMA KITK880674MICROMEDIC CRACKPOT RIA KIT

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.K011011LIVESURE MORPHINE SCREEN TESTPan Probe Biotech, 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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