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FDA 510(k)

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS

K-Number: K981497 · 1998-10-29

ApplicantSteritec Products Mfg Co, Inc.
Decision Date1998-10-29
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg Co, Inc.. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K981497. 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 STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS?

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K981497.

When did STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS receive FDA 510(k) clearance?

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS received FDA 510(k) clearance on 1998-10-29, under 510(k) number K981497.

Who is the listed applicant for STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS?

The FDA 510(k) record lists Steritec Products Mfg Co, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS?

The FDA product code for STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS is FRC.

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Other records listing Steritec Products Mfg Co, Inc. as applicant

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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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