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FDA 510(k)

BIOLOGICAL INDICATOR - KEMMED & BIOSURE

K-Number: K802228 · 1980-12-09

ApplicantKem Medical Products Corp.
Decision Date1980-12-09
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOLOGICAL INDICATOR - KEMMED & BIOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Kem Medical Products Corp.. It received FDA 510(k) clearance on 1980-12-09 under 510(k) number K802228. 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 INDICATOR - KEMMED & BIOSURE?

BIOLOGICAL INDICATOR - KEMMED & BIOSURE is a medical device that received FDA 510(k) clearance on 1980-12-09. The listed applicant is Kem Medical Products Corp.. The 510(k) number is K802228.

When did BIOLOGICAL INDICATOR - KEMMED & BIOSURE receive FDA 510(k) clearance?

BIOLOGICAL INDICATOR - KEMMED & BIOSURE received FDA 510(k) clearance on 1980-12-09, under 510(k) number K802228.

Who is the listed applicant for BIOLOGICAL INDICATOR - KEMMED & BIOSURE?

The FDA 510(k) record lists Kem Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLOGICAL INDICATOR - KEMMED & BIOSURE?

The FDA product code for BIOLOGICAL INDICATOR - KEMMED & BIOSURE is FRC.

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Other records listing Kem Medical Products Corp. 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.

K181788Lead-free Chemical Indicators for Steam SterilizationK802229CHEMICAL INDICATOR - KEM MED & BIO SURE

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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