The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Ontrak Teststik For Morphine 2000 (m2k).
| Device ID | K990409 |
| 510k Number | K990409 |
| Device Name: | ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) |
| Classification | Gas Chromatography, Morphine |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Jennifer L Tribbett |
| Correspondent | Jennifer L Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DMY |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-09 |
| Decision Date | 1999-04-15 |
| Summary: | summary |