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FDA 510(k)

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.

K-Number: K863122 · 1986-12-17

ApplicantSurgicot, Inc.
Decision Date1986-12-17
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1986-12-17 under 510(k) number K863122. 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 BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.?

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. is a medical device that received FDA 510(k) clearance on 1986-12-17. The listed applicant is Surgicot, Inc.. The 510(k) number is K863122.

When did ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. receive FDA 510(k) clearance?

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. received FDA 510(k) clearance on 1986-12-17, under 510(k) number K863122.

Who is the listed applicant for ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.?

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 BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.?

The FDA product code for ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. 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 CLEANERK855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORK854631ASSERT 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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