LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set— 510(k) K161139
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K161139 for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set, Substantially Equivalent on 2016-07-22. 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.