LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set— 510(k) K181464
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K181464 for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set, Substantially Equivalent on 2018-08-31. Applicant: DiaSorin, Inc.. Device class: 1.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code LYR
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
Recent devices under product code LYR
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
- K223403 — LIAISON Anti-HAV; LIAISON XS
- K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.