510(k) K160990

Device: Nova Max Uric Acid Monitoring System
Applicant: NOVA BIOMEDICAL CORPORATION
510(k) number: K160990
Product code: PTC
Decision: Substantially Equivalent (SESE)
Decision date: 2017-04-11
Date received: 2016-04-08
Regulation: 862.1775
Classification name: Uric Acid Test System For At Home Prescription Use
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ELIZA WANG
Address: 200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers#

1219029
3004145393
9616936
3011979858
3004193489

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PTC #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242209	UASure II Blood Uric Acid Monitoring System	Apex BioTechnology Corp.	2025-04-04
K181675	FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System	Taidoc Technology Corporation	2018-12-10

Legacy Summary#

summary

FDA Review#

Decision Summary