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FDA 510(k)

ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR

K-Number: K923739 · 1994-12-22

ApplicantAbtox, Inc.
Decision Date1994-12-22
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Abtox, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K923739. 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 ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR?

ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Abtox, Inc.. The 510(k) number is K923739.

When did ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR receive FDA 510(k) clearance?

ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR received FDA 510(k) clearance on 1994-12-22, under 510(k) number K923739.

Who is the listed applicant for ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR?

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

What is the FDA product code for ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR?

The FDA product code for ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR 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 Abtox, 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.

K923442ABTOX PLAZLYTE PROCESS MONITORK905119PLAZLYTE(TM)

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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