LIAISON Anti-HAV Assay— 510(k) K193532
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K193532 for LIAISON Anti-HAV Assay, Substantially Equivalent on 2020-03-02. Applicant: DiaSorin, Inc.. Device class: 2.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code LOL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3310
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
Recent devices under product code LOL
view allMore clearances from DiaSorin, Inc.
view all- K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
- K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set
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