SHIELD HELICO-G2 ELISA KIT— 510(k) K972981
Substantially EquivalentShield Diagnostics, Ltd.
FDA 510(k) clearance K972981 for SHIELD HELICO-G2 ELISA KIT, Substantially Equivalent on 1998-03-17. Applicant: Shield Diagnostics, Ltd.. Device class: 1.
Clearance details
- Applicant
- Shield Diagnostics, Ltd.
- 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
- Dundee, GB
Recent devices under product code LYR
view allMore clearances from Shield Diagnostics, Ltd.
view all- K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
- K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
- K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
- K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
- K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
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.