The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Elecsys Pth Test System.
| Device ID | K070709 |
| 510k Number | K070709 |
| Device Name: | ROCHE ELECSYS PTH TEST SYSTEM |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630939787 | K070709 | 000 |
| 04015630939244 | K070709 | 000 |
| 04015630939237 | K070709 | 000 |
| 04015630913121 | K070709 | 000 |