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FDA 510(k)

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH

K-Number: K850144 · 1985-06-17

ApplicantAmerican Sterilizer Co.
Decision Date1985-06-17
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1985-06-17 under 510(k) number K850144. 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 BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH?

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH is a medical device that received FDA 510(k) clearance on 1985-06-17. The listed applicant is American Sterilizer Co.. The 510(k) number is K850144.

When did BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH receive FDA 510(k) clearance?

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH received FDA 510(k) clearance on 1985-06-17, under 510(k) number K850144.

Who is the listed applicant for BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH?

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

What is the FDA product code for BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH?

The FDA product code for BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH is FRC.

Related Clinical Trials

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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Other records listing American Sterilizer 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

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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

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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