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FDA 510(k)

CASTLE TEC-TEST S.M.A.R.T. PACK

K-Number: K833074 · 1983-11-07

ApplicantCastle Co.
Decision Date1983-11-07
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CASTLE TEC-TEST S.M.A.R.T. PACK is the device name listed in this FDA 510(k) record. The listed applicant is Castle Co.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833074. 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 CASTLE TEC-TEST S.M.A.R.T. PACK?

CASTLE TEC-TEST S.M.A.R.T. PACK is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Castle Co.. The 510(k) number is K833074.

When did CASTLE TEC-TEST S.M.A.R.T. PACK receive FDA 510(k) clearance?

CASTLE TEC-TEST S.M.A.R.T. PACK received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833074.

Who is the listed applicant for CASTLE TEC-TEST S.M.A.R.T. PACK?

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

What is the FDA product code for CASTLE TEC-TEST S.M.A.R.T. PACK?

The FDA product code for CASTLE TEC-TEST S.M.A.R.T. PACK is JOJ.

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Other records listing Castle Co. 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.

K870975MODIFIED CASTLE POWERCLAVEK860263CASTLE 7538 FLOOR LOADING WASHERK844089CASTLE 7515 UTENSIL/GLASSWARE WASHERK834048BOVIE CONDUCTIVE ADHES-DISPER-ELECTROK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AERK792649UNISPORE-BIOLOGICAL INDICATORS

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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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