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FDA 510(k)

LIAISON EBV IgM Serum Control Set

K-Number: K161522 · 2016-06-30

ApplicantDiaSorin, Inc.
Decision Date2016-06-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIAISON EBV IgM Serum Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161522. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON EBV IgM Serum Control Set?

LIAISON EBV IgM Serum Control Set is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161522.

When did LIAISON EBV IgM Serum Control Set receive FDA 510(k) clearance?

LIAISON EBV IgM Serum Control Set received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161522.

Who is the listed applicant for LIAISON EBV IgM Serum Control Set?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIAISON EBV IgM Serum Control Set?

The FDA product code for LIAISON EBV IgM Serum Control Set is JJX.

Other records listing DiaSorin, 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.

PMA P250039ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGMPMA P220034ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGGK260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXPMA P180047TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSISPMA P190017Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)PMA P180049Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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Related Devices (Code: JJX)

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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