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FDA 510(k)

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

K-Number: K073537 · 2008-06-27

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2008-06-27
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K073537. 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 NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265?

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K073537.

When did NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 receive FDA 510(k) clearance?

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 received FDA 510(k) clearance on 2008-06-27, under 510(k) number K073537.

Who is the listed applicant for NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265?

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

What is the FDA product code for NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265?

The FDA product code for NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 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.

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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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