The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Parathyroid Hormone Test System.
| Device ID | K992680 |
| 510k Number | K992680 |
| Device Name: | ELECSYS PARATHYROID HORMONE TEST SYSTEM |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-10 |
| Decision Date | 1999-09-28 |
| Summary: | summary |