The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics,inc. with the FDA for Trinidad Im Thyroid Stimulating Hormone (tsh) Assay, Trinidad Im Tsh Calibrators, Trinidad Immunoassay (im) System.
| Device ID | K151792 |
| 510k Number | K151792 |
| Device Name: | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Siemens Healthcare Diagnostics,Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu Siemens Healthcare Diagnostics,Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JLW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595931 | K151792 | 000 |
| 00630414595924 | K151792 | 000 |
| 00630414595542 | K151792 | 000 |
| 00630414007960 | K151792 | 000 |
| 00630414002026 | K151792 | 000 |
| 00630414613437 | K151792 | 000 |
| 00630414613239 | K151792 | 000 |