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FDA 510(k)

GENESIS RMP

K-Number: K963268 · 1997-03-18

ApplicantTecan U.S., Inc.
Decision Date1997-03-18
Product CodeJRA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENESIS RMP is the device name listed in this FDA 510(k) record. The listed applicant is Tecan U.S., Inc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K963268. The device is classified under product code JRA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS RMP?

GENESIS RMP is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Tecan U.S., Inc.. The 510(k) number is K963268.

When did GENESIS RMP receive FDA 510(k) clearance?

GENESIS RMP received FDA 510(k) clearance on 1997-03-18, under 510(k) number K963268.

Who is the listed applicant for GENESIS RMP?

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

What is the FDA product code for GENESIS RMP?

The FDA product code for GENESIS RMP is JRA.

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 Tecan U.S., 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.

K953345GENESISK9445564 CHANNEL DISPENSERK9426554 CHANNEL DISPENSER

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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