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FDA 510(k)

RAPIDPOINT 405 NEONATAL BILIRUBIN

K-Number: K110277 · 2011-08-15

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-08-15
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAPIDPOINT 405 NEONATAL BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2011-08-15 under 510(k) number K110277. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDPOINT 405 NEONATAL BILIRUBIN?

RAPIDPOINT 405 NEONATAL BILIRUBIN is a medical device that received FDA 510(k) clearance on 2011-08-15. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K110277.

When did RAPIDPOINT 405 NEONATAL BILIRUBIN receive FDA 510(k) clearance?

RAPIDPOINT 405 NEONATAL BILIRUBIN received FDA 510(k) clearance on 2011-08-15, under 510(k) number K110277.

Who is the listed applicant for RAPIDPOINT 405 NEONATAL BILIRUBIN?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDPOINT 405 NEONATAL BILIRUBIN?

The FDA product code for RAPIDPOINT 405 NEONATAL BILIRUBIN is MQM.

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Related Devices (Code: MQM)

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.

K170882ABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical ApsK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions DiagnosticsK042522JAUNDICE METER, MODEL JM 103Draeger Medical Infant Care, Inc.K040174BILIRUBIN ASSAY ON THE OMNI S ANALYZERRoche Diagnostics Corp.K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103Hill-Rom Air-ShieldsK001687COLORMATE TLC BILITEST SYSTEMChromatics Color Sciences Intl., 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.

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