FDA device listing
PORPHYRINS BY HPLC TEST
FDA device listing 2005331634 · CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
Key facts
| Proprietary names | PORPHYRINS BY HPLC TEST |
|---|---|
| Owner/operator | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
| Owner/operator number | 9067715 |
| Product codes | JKJ |
| Device names | JKJ - Fluorometric Measurement, Porphyrins |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1595 |
| Review panels | Clinical Chemistry |
| Registered establishments | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
| Establishment registrations | 3003951180 |
| FEI numbers | 3003951180 |
| 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