The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite Igf Control Module, Immulite Gastrin Control Module.
| Device ID | K150132 |
| 510k Number | K150132 |
| Device Name: | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Asha Gartland |
| Correspondent | Asha Gartland Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-21 |
| Decision Date | 2015-04-13 |
| Summary: | summary |