The following data is part of a premarket notification filed by Olympus Life Science Research Europa Gmbh (europa) with the FDA for Olympus Direct Bilirubin Reagent, Model Osr6x181.
| Device ID | K080435 |
| 510k Number | K080435 |
| Device Name: | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3500 CORPORATE PKWAY Center Valley, PA 18034 |
| Contact | Stephanie G Donnelly |
| Correspondent | Stephanie G Donnelly OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3500 CORPORATE PKWAY Center Valley, PA 18034 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590011680 | K080435 | 000 |