ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE— 510(k) K024350
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K024350 for ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE, Substantially Equivalent on 2003-04-02. Applicant: ACON Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- ACON Laboratories, 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
- San Diego, CA, US
Recent devices under product code LYR
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- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
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.