The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Precinorm Ck-mb And Precipath Ck-mb Controls.
| Device ID | K062972 |
| 510k Number | K062972 |
| Device Name: | PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Contact | Kerwin L Kaufman |
| Correspondent | Kerwin L Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2006-10-13 |
| Summary: | summary |