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FDA 510(k)

RAPIDEC UR

K-Number: K894805 · 1989-09-26

ApplicantDms Products, Inc.
Decision Date1989-09-26
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPIDEC UR is the device name listed in this FDA 510(k) record. The listed applicant is Dms Products, Inc.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K894805. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDEC UR?

RAPIDEC UR is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Dms Products, Inc.. The 510(k) number is K894805.

When did RAPIDEC UR receive FDA 510(k) clearance?

RAPIDEC UR received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894805.

Who is the listed applicant for RAPIDEC UR?

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

What is the FDA product code for RAPIDEC UR?

The FDA product code for RAPIDEC UR is JXA.

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 Dms Products, 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.

K891004RAPIDEC STAPHK890626RAPIDEC COLIK890625JAMES REAGENTK854733API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)K854732API 50 CHB (CULTURE MEDIA)

Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, 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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