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)

UNISTRIP 1

K-Number: K113135 · 2013-11-06

ApplicantUnistrip Technologies, LLC
Decision Date2013-11-06
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNISTRIP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Unistrip Technologies, LLC. It received FDA 510(k) clearance on 2013-11-06 under 510(k) number K113135. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTRIP 1?

UNISTRIP 1 is a medical device that received FDA 510(k) clearance on 2013-11-06. The listed applicant is Unistrip Technologies, LLC. The 510(k) number is K113135.

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

UNISTRIP 1 received FDA 510(k) clearance on 2013-11-06, under 510(k) number K113135.

Who is the listed applicant for UNISTRIP 1?

The FDA 510(k) record lists Unistrip Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISTRIP 1?

The FDA product code for UNISTRIP 1 is NBW. This falls under the OB/GYN category.

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

Related Devices (Code: NBW)

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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.

↑