The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Dat Ii Cannabinoids Ii.
| Device ID | K030213 |
| 510k Number | K030213 |
| Device Name: | ONLINE DAT II CANNABINOIDS II |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336166239 | K030213 | 000 |
| 07613336121511 | K030213 | 000 |
| 04015630997770 | K030213 | 000 |
| 04015630996681 | K030213 | 000 |