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FDA 510(k)

STEAM STERILIZATION INDICATOR

K-Number: K771080 · 1977-07-14

ApplicantInfo-Chem
Decision Date1977-07-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEAM STERILIZATION INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Info-Chem. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771080. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEAM STERILIZATION INDICATOR?

STEAM STERILIZATION INDICATOR is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Info-Chem. The 510(k) number is K771080.

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

STEAM STERILIZATION INDICATOR received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771080.

Who is the listed applicant for STEAM STERILIZATION INDICATOR?

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

What is the FDA product code for STEAM STERILIZATION INDICATOR?

The FDA product code for STEAM STERILIZATION INDICATOR is FRC.

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Other records listing Info-Chem 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.

K810134KEEP-ACCOUNT SHARPS DISPOSAL SYSTEMK791574MODIFIED TEMPA-DOT THERMOMETERK772233THERMOMETER RECAL ADAPTERK771037THERMOMETER, SINGLE USE, STRIP, TEMPADOT

Related Devices (Code: FRC)

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.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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