The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Pth Test System.
Device ID | K070391 |
510k Number | K070391 |
Device Name: | 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-09 |
Decision Date | 2007-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04015630940776 | K070391 | 000 |
04015630922895 | K070391 | 000 |