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)

WELLPREP 1

K-Number: K913567 · 1991-10-04

ApplicantDenley Instruments, Inc.
Decision Date1991-10-04
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WELLPREP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Denley Instruments, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913567. 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 WELLPREP 1?

WELLPREP 1 is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Denley Instruments, Inc.. The 510(k) number is K913567.

When did WELLPREP 1 receive FDA 510(k) clearance?

WELLPREP 1 received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913567.

Who is the listed applicant for WELLPREP 1?

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

What is the FDA product code for WELLPREP 1?

The FDA product code for WELLPREP 1 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 Denley Instruments, 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.

K922803WELLWASH 4 MARK IIK922327DENLEY WELLPREP 2 SAMPLE PROCESSORK922183WELLPREP 2000 SAMPLE PROCESSORK915284STACKING MICROPLATE WASHERK900599MICROPLATE REAGENT DISPENSERK894272DENLEY WELLDILL 3

View all 9 devices →

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.

↑