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)

INDISTRIP GREEN

K-Number: K110369 · 2011-05-06

ApplicantIndilab, Inc.
Decision Date2011-05-06
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INDISTRIP GREEN is the device name listed in this FDA 510(k) record. The listed applicant is Indilab, Inc.. It received FDA 510(k) clearance on 2011-05-06 under 510(k) number K110369. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDISTRIP GREEN?

INDISTRIP GREEN is a medical device that received FDA 510(k) clearance on 2011-05-06. The listed applicant is Indilab, Inc.. The 510(k) number is K110369.

When did INDISTRIP GREEN receive FDA 510(k) clearance?

INDISTRIP GREEN received FDA 510(k) clearance on 2011-05-06, under 510(k) number K110369.

Who is the listed applicant for INDISTRIP GREEN?

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

What is the FDA product code for INDISTRIP GREEN?

The FDA product code for INDISTRIP GREEN is JOJ.

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 Indilab, 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.

K875193INDISTRIP (STERILIZATION PROCESS INDICATOR)

Related Devices (Code: JOJ)

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.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

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.

↑