The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To:roche Diagnostics Precinorm Universal And Precipath Universal Control Sera.
| Device ID | K041227 |
| 510k Number | K041227 |
| Device Name: | MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-05-27 |
| Summary: | summary |