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FDA 510(k)

LAMBDA LIGHT CHAINS

K-Number: K083601 · 2009-06-22

ApplicantSENTINEL CH. SpA
Decision Date2009-06-22
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAMBDA LIGHT CHAINS is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2009-06-22 under 510(k) number K083601. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMBDA LIGHT CHAINS?

LAMBDA LIGHT CHAINS is a medical device that received FDA 510(k) clearance on 2009-06-22. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K083601.

When did LAMBDA LIGHT CHAINS receive FDA 510(k) clearance?

LAMBDA LIGHT CHAINS received FDA 510(k) clearance on 2009-06-22, under 510(k) number K083601.

Who is the listed applicant for LAMBDA LIGHT CHAINS?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMBDA LIGHT CHAINS?

The FDA product code for LAMBDA LIGHT CHAINS is DEH.

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Related Devices (Code: DEH)

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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