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FDA 510(k)

ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR

K-Number: K855101 · 1986-07-17

ApplicantSurgicot, Inc.
Decision Date1986-07-17
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1986-07-17 under 510(k) number K855101. 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 ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR?

ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR is a medical device that received FDA 510(k) clearance on 1986-07-17. The listed applicant is Surgicot, Inc.. The 510(k) number is K855101.

When did ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR receive FDA 510(k) clearance?

ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR received FDA 510(k) clearance on 1986-07-17, under 510(k) number K855101.

Who is the listed applicant for ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR?

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

What is the FDA product code for ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR?

The FDA product code for ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR is FRC.

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Other records listing Surgicot, 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.

K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERK863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.K854631ASSERT EO BIOLOGICAL TEST PACKK854902SURGICOT STEAM TEST PACKK840541NEURO SPONGE

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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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