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FDA 510(k)

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

K-Number: K093794 · 2010-05-14

ApplicantSgm Biotech, Inc.
Decision Date2010-05-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART-READ EZTEST-STEAM SCBI AND TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Sgm Biotech, Inc.. It received FDA 510(k) clearance on 2010-05-14 under 510(k) number K093794. 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 SMART-READ EZTEST-STEAM SCBI AND TEST PACK?

SMART-READ EZTEST-STEAM SCBI AND TEST PACK is a medical device that received FDA 510(k) clearance on 2010-05-14. The listed applicant is Sgm Biotech, Inc.. The 510(k) number is K093794.

When did SMART-READ EZTEST-STEAM SCBI AND TEST PACK receive FDA 510(k) clearance?

SMART-READ EZTEST-STEAM SCBI AND TEST PACK received FDA 510(k) clearance on 2010-05-14, under 510(k) number K093794.

Who is the listed applicant for SMART-READ EZTEST-STEAM SCBI AND TEST PACK?

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

What is the FDA product code for SMART-READ EZTEST-STEAM SCBI AND TEST PACK?

The FDA product code for SMART-READ EZTEST-STEAM SCBI AND TEST PACK 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 Sgm Biotech, 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.

K091950SMART-WELL EZTEST INCUBATORK963841EZTESTK930682EZTEST-STEAM

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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