The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Trinidad Ch System, Td-lyte Integrated Multisensor (na, K, Ci), Td-lyte Imt Standard A, Td-lyte Imt Standard B + Salt Bridge, Trinidad Ch Albumin Bcp Reagent (alb_p), Trinidad Ch Albumin Bcp Calibrator.
| Device ID | K151767 |
| 510k Number | K151767 |
| Device Name: | Trinidad CH System, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP Reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE PO BOX 6101 MS 514 Newark, DE 19711 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, M/S 514 PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CJW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-30 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597201 | K151767 | 000 |
| 00630414595757 | K151767 | 000 |
| 00630414595733 | K151767 | 000 |
| 00630414595726 | K151767 | 000 |
| 00630414595702 | K151767 | 000 |
| 00630414595696 | K151767 | 000 |
| 00630414595689 | K151767 | 000 |
| 00630414002347 | K151767 | 000 |
| 00630414002163 | K151767 | 000 |
| 00630414297651 | K151767 | 000 |
| 00630414595764 | K151767 | 000 |
| 00630414595771 | K151767 | 000 |
| 00630414595788 | K151767 | 000 |
| 00630414596518 | K151767 | 000 |
| 00630414595825 | K151767 | 000 |
| 00630414595740 | K151767 | 000 |
| 00630414595719 | K151767 | 000 |
| 00630414002354 | K151767 | 000 |
| 00630414596556 | K151767 | 000 |
| 00630414596549 | K151767 | 000 |
| 00630414596532 | K151767 | 000 |
| 00630414596150 | K151767 | 000 |
| 00630414297682 | K151767 | 000 |