FDA 510(k)

Elecsys HCG STAT

K-Number: K203227 · 2021-08-18

Decision Date2021-08-18

Product CodeDHA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Elecsys HCG STAT is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2021-08-18 under approval number K203227. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys HCG STAT?

Elecsys HCG STAT is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by Roche Diagnostics. The 510(k) number is K203227.

When was Elecsys HCG STAT approved by the FDA?

Elecsys HCG STAT received FDA 510(k) clearance on 2021-08-18, under approval number K203227.

What company makes Elecsys HCG STAT?

Elecsys HCG STAT is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys HCG STAT?

The FDA product code for Elecsys HCG STAT is DHA.

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Related Devices (Code: DHA)

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories K163418Diazyme DZ-Lite Total beta-hCG Test SystemDiazyme Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K200210ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc.

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.