# Gradipore, Ltd.

- Location (FDA's records): Pyrmont, AU
- FDA decisions: 4 (1990–2000): 4 510(k) clearances
- Product codes: GIR (2), GGC (1), GGW (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/medical-diagnostic-technologies)

## Firms that cite its devices most
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Precision Biologic: 1 (https://510kreport.com/company/precision-biologic)

## Its most-cited devices
- K922156: Lucor Confirmatory Reagent (1993), cited by 1
- K992456: Gradileiden V Test (1999), cited by 1

## Recent decisions
- K993332: Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05 (Feb 16, 2000)
- K992456: Gradileiden V Test (Dec 21, 1999)
- K922156: Lucor Confirmatory Reagent (Apr 6, 1993)
- K903037: Lupo-Test Reagent (Dec 17, 1990)

Source page: https://510kreport.com/company/gradipore