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FDA 510(k)

48 HOUR BIOLOGICAL INDICATORS SPORSTRIP

K-Number: K841709 · 1984-10-02

ApplicantSkyland Scientific Services, Inc.
Decision Date1984-10-02
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

48 HOUR BIOLOGICAL INDICATORS SPORSTRIP is the device name listed in this FDA 510(k) record. The listed applicant is Skyland Scientific Services, Inc.. It received FDA 510(k) clearance on 1984-10-02 under 510(k) number K841709. 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 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP?

48 HOUR BIOLOGICAL INDICATORS SPORSTRIP is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Skyland Scientific Services, Inc.. The 510(k) number is K841709.

When did 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP receive FDA 510(k) clearance?

48 HOUR BIOLOGICAL INDICATORS SPORSTRIP received FDA 510(k) clearance on 1984-10-02, under 510(k) number K841709.

Who is the listed applicant for 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP?

The FDA 510(k) record lists Skyland Scientific Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP?

The FDA product code for 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP is FRC.

Related Clinical Trials

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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Other records listing Skyland Scientific Services, 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.

K910417EVIDENCE BIOLOGICAL INDICATORK841583SPORSTRIP

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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