FDA device listing
Radioassay, Vitamin B12
FDA device listing 2051194873 · Supply Max NY Inc
Key facts
| Owner/operator | Supply Max NY Inc |
|---|---|
| Owner/operator number | 10093056 |
| Premarket submissions | K041133 |
| Product codes | CDD, CDP, CDZ, CEC, CEP, CEW, CFT, CGJ, CGN, DDR, DGC, DIS and 17 more |
| Device names | CDD - Radioassay, Vitamin B12, CDP - Radioimmunoassay, Total Triiodothyronine, CDZ - Radioimmunoassay, Testosterones And Dihydrotestosterone, CEC - Radioimmunoassay, Free Thyroxine, CEP - Radioimmunoassay, Luteinizing Hormone, CEW - Radioimmunoassay, Parathyroid Hormone, CFT - Radioimmunoassay, Prolactin (Lactogen), CGJ - Radioimmunoassay, Follicle-Stimulating Hormone, CGN - Acid, Folic, Radioimmunoassay, DDR - Myoglobin, Antigen, Antiserum, Control, DGC - Ige, Antigen, Antiserum, Control, DIS - Enzyme Immunoassay, Barbiturate and 17 more |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1155, 862.1295, 862.1300, 862.1377, 862.1485, 862.1545, 862.1620, 862.1625, 862.1660, 862.1680, 862.1690 and 17 more |
| Review panels | Clinical Chemistry, Clinical Toxicology, Immunology, Microbiology |
| Registered establishments | SUPPLY MAX NY INC |
| Establishment registrations | 3033967997 |
| FEI numbers | 3033967997 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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