Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMART-WELL EZTEST INCUBATOR

K-Number: K091950 · 2010-01-15

ApplicantSgm Biotech, Inc.
Decision Date2010-01-15
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART-WELL EZTEST INCUBATOR 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 2010-01-15 under 510(k) number K091950. 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-WELL EZTEST INCUBATOR?

SMART-WELL EZTEST INCUBATOR is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Sgm Biotech, Inc.. The 510(k) number is K091950.

When did SMART-WELL EZTEST INCUBATOR receive FDA 510(k) clearance?

SMART-WELL EZTEST INCUBATOR received FDA 510(k) clearance on 2010-01-15, under 510(k) number K091950.

Who is the listed applicant for SMART-WELL EZTEST INCUBATOR?

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-WELL EZTEST INCUBATOR?

The FDA product code for SMART-WELL EZTEST INCUBATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K093794SMART-READ EZTEST-STEAM SCBI AND TEST PACKK963841EZTESTK930682EZTEST-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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑