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FDA 510(k)

STERITEC GREEN CARD PACK BOWIE-DICK TEST

K-Number: K132372 · 2013-11-26

ApplicantSteritec Products Mfg Co, Inc.
Decision Date2013-11-26
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC GREEN CARD PACK BOWIE-DICK TEST 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 2013-11-26 under 510(k) number K132372. 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 GREEN CARD PACK BOWIE-DICK TEST?

STERITEC GREEN CARD PACK BOWIE-DICK TEST is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K132372.

When did STERITEC GREEN CARD PACK BOWIE-DICK TEST receive FDA 510(k) clearance?

STERITEC GREEN CARD PACK BOWIE-DICK TEST received FDA 510(k) clearance on 2013-11-26, under 510(k) number K132372.

Who is the listed applicant for STERITEC GREEN CARD PACK BOWIE-DICK TEST?

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 GREEN CARD PACK BOWIE-DICK TEST?

The FDA product code for STERITEC GREEN CARD PACK BOWIE-DICK TEST is JOJ.

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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 IntegratorK122945STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126K122555STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPEK111150STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATORK103000SMART READ BIOLOGICAL TEST PACKK072408EMU-GRAPH EMULATOR, MODEL CI 131

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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.

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