The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Acetaminophen Assay.
| Device ID | K110726 |
| 510k Number | K110726 |
| Device Name: | ROCHE ACETAMINOPHEN ASSAY |
| Classification | Colorimetry, Acetaminophen |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630946372 | K110726 | 000 |