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FDA 510(k)

CHEMICAL INDICATORS

K-Number: K812856 · 1981-11-06

ApplicantSterilization Technical Services, Inc.
Decision Date1981-11-06
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEMICAL INDICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilization Technical Services, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812856. 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 CHEMICAL INDICATORS?

CHEMICAL INDICATORS is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Sterilization Technical Services, Inc.. The 510(k) number is K812856.

When did CHEMICAL INDICATORS receive FDA 510(k) clearance?

CHEMICAL INDICATORS received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812856.

Who is the listed applicant for CHEMICAL INDICATORS?

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

What is the FDA product code for CHEMICAL INDICATORS?

The FDA product code for CHEMICAL INDICATORS is JOJ.

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Other records listing Sterilization Technical Services, 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.

K802509G.R.A.M. SLIDEK801678SPOR-TEST-STRIP

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

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