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FDA 510(k)

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS

K-Number: K113302 · 2012-01-20

ApplicantNorth American Science Assoc., Inc.
Decision Date2012-01-20
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS is the device name listed in this FDA 510(k) record. The listed applicant is North American Science Assoc., Inc.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K113302. 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 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS?

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is North American Science Assoc., Inc.. The 510(k) number is K113302.

When did NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS receive FDA 510(k) clearance?

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113302.

Who is the listed applicant for NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS?

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

What is the FDA product code for NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS?

The FDA product code for NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS is FRC.

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Other records listing North American Science Assoc., 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.

K113221NAMSA BIOLOGICAL INDICATOR SPORE STRIPSK983451CHALLENGE TEST PACKK962649SPORTROL RAPID STERILITY INDICATOR

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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