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FDA 510(k)

GENESIS

K-Number: K953345 · 1995-11-21

ApplicantTecan U.S., Inc.
Decision Date1995-11-21
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENESIS 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 1995-11-21 under 510(k) number K953345. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS?

GENESIS is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Tecan U.S., Inc.. The 510(k) number is K953345.

When did GENESIS receive FDA 510(k) clearance?

GENESIS received FDA 510(k) clearance on 1995-11-21, under 510(k) number K953345.

Who is the listed applicant for GENESIS?

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?

The FDA product code for GENESIS is JQW.

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.

K963268GENESIS RMPK9445564 CHANNEL DISPENSERK9426554 CHANNEL DISPENSER

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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