The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Acetaminophen.
| Device ID | K013757 |
| 510k Number | K013757 |
| Device Name: | ROCHE ACETAMINOPHEN |
| Classification | Colorimetry, Acetaminophen |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Mike Flis |
| Correspondent | Mike Flis ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-08 |
| Summary: | summary |