INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST— 510(k) K024360
Substantially EquivalentAlfa Scientific Designs, Inc.
FDA 510(k) clearance K024360 for INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST, Substantially Equivalent on 2003-06-10. Applicant: Alfa Scientific Designs, Inc.. Device class: 1.
Clearance details
- Applicant
- Alfa Scientific Designs, 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
- Poway, CA, US
Recent devices under product code LYR
view allMore clearances from Alfa Scientific Designs, Inc.
view all- K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
- K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test
- K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
- K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
- K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
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.