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FDA 510(k)

ASSERT EO BIOLOGICAL TEST PACK

K-Number: K854631 · 1986-05-27

ApplicantSurgicot, Inc.
Decision Date1986-05-27
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASSERT EO BIOLOGICAL TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1986-05-27 under 510(k) number K854631. 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 EO BIOLOGICAL TEST PACK?

ASSERT EO BIOLOGICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1986-05-27. The listed applicant is Surgicot, Inc.. The 510(k) number is K854631.

When did ASSERT EO BIOLOGICAL TEST PACK receive FDA 510(k) clearance?

ASSERT EO BIOLOGICAL TEST PACK received FDA 510(k) clearance on 1986-05-27, under 510(k) number K854631.

Who is the listed applicant for ASSERT EO BIOLOGICAL TEST PACK?

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 EO BIOLOGICAL TEST PACK?

The FDA product code for ASSERT EO BIOLOGICAL TEST PACK 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.K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854902SURGICOT 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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