FDA device listing
DECALCIFIER I,DECALCIFIER I 4 GL/CASE,DECALCIFIER I 6 QT/CASE,DECALCIFIER I GALLON,DECALCIFIER II 2.5 GL…
FDA device listing 1279653654 · Leica Biosystems, division of Leica Microsystems, Inc.
Key facts
| Proprietary names | DECALCIFIER I,DECALCIFIER I 4 GL/CASE,DECALCIFIER I 6 QT/CASE,DECALCIFIER I GALLON,DECALCIFIER II 2.5 GL CUBE,DECALCIFIER II 4 GL/CASE,DECALCIFIER II 6 QT/CASE,DECALCIFIER II GALLON,Decalcifier II, Gallon (3.8L) 1 Case of 4 pieces,Decalcifier II Gallon (3.8L) 1 Gallon 1 Gallon,DECALCIFIER II QUART,DECALCIFIER I QUART,Decal I Modified, 55 Gallon Drum 1 Drum |
|---|---|
| Owner/operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Owner/operator number | 10054155 |
| Product codes | LDW |
| Device names | LDW - Fixative, Acid Containing |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | Leica Biosystems Richmond, Inc. |
| Establishment registrations | 1419341 |
| FEI numbers | 1419341 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database