Atlas FDA

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

FDA 510(k) clearance K181464 · decided 2018-08-31

Clearance details

K-number
K181464
Device name
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2018-06-04
Decision date
2018-08-31
Days to decision
88 days
Clearance type
Traditional
Product code
LYR
Device class
1
Regulation number
866.3110
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041)DiaSorin, Inc.2025-12-19
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LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021)DiaSorin, Inc.2025-10-10
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LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020)DiaSorin, Inc.2025-10-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021)DiaSorin, Inc.2025-10-10