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FDA 510(k)

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS

K-Number: K113221 · 2012-04-27

ApplicantNorth American Science Assoc., Inc.
Decision Date2012-04-27
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS 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 2012-04-27 under 510(k) number K113221. 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 BIOLOGICAL INDICATOR SPORE STRIPS?

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is North American Science Assoc., Inc.. The 510(k) number is K113221.

When did NAMSA BIOLOGICAL INDICATOR SPORE STRIPS receive FDA 510(k) clearance?

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS received FDA 510(k) clearance on 2012-04-27, under 510(k) number K113221.

Who is the listed applicant for NAMSA BIOLOGICAL INDICATOR SPORE STRIPS?

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 BIOLOGICAL INDICATOR SPORE STRIPS?

The FDA product code for NAMSA BIOLOGICAL INDICATOR SPORE STRIPS 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.

K113302NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORSK983451CHALLENGE 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.

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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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