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)

STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE

K-Number: K122555 · 2012-12-12

ApplicantSteritec Products Mfg Co, Inc.
Decision Date2012-12-12
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg Co, Inc.. It received FDA 510(k) clearance on 2012-12-12 under 510(k) number K122555. 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 STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE?

STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K122555.

When did STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE receive FDA 510(k) clearance?

STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE received FDA 510(k) clearance on 2012-12-12, under 510(k) number K122555.

Who is the listed applicant for STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE?

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

What is the FDA product code for STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE?

The FDA product code for STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE 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 Steritec Products Mfg Co, 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.

K200252Getinge Assured MI Steam Migrating IntegratorK132372STERITEC GREEN CARD PACK BOWIE-DICK TESTK122945STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126K111150STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATORK103000SMART READ BIOLOGICAL TEST PACKK072408EMU-GRAPH EMULATOR, MODEL CI 131

View all 20 devices →

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.

↑