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FDA 510(k)

CLASSIX CHEMICAL STERILIZATION INDICATOR

K-Number: K102894 · 2011-05-25

ApplicantPropper Mfg. Co., Inc.
Decision Date2011-05-25
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLASSIX CHEMICAL STERILIZATION INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Propper Mfg. Co., Inc.. It received FDA 510(k) clearance on 2011-05-25 under 510(k) number K102894. 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 CLASSIX CHEMICAL STERILIZATION INDICATOR?

CLASSIX CHEMICAL STERILIZATION INDICATOR is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K102894.

When did CLASSIX CHEMICAL STERILIZATION INDICATOR receive FDA 510(k) clearance?

CLASSIX CHEMICAL STERILIZATION INDICATOR received FDA 510(k) clearance on 2011-05-25, under 510(k) number K102894.

Who is the listed applicant for CLASSIX CHEMICAL STERILIZATION INDICATOR?

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

What is the FDA product code for CLASSIX CHEMICAL STERILIZATION INDICATOR?

The FDA product code for CLASSIX CHEMICAL STERILIZATION INDICATOR is JOJ.

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Other records listing Propper 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.

K111453STEAM DOT BLU PROCESS INDICATORK082620ONCE-A-DAY VERTOS TEST PACKK031152PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)K991618BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATORK991276PASS/FAIL CHALLENGE PACKK973585PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR

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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.

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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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