The following data is part of a premarket notification filed by Varian Inc with the FDA for Modification To Ontrak Testcup Ii And Onsite Cupkit.
| Device ID | K060896 |
| 510k Number | K060896 |
| Device Name: | MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | VARIAN INC 25200 COMMERCENTRE DR. Lake Forest, CA 92630 -8810 |
| Contact | Lorna Gamboa |
| Correspondent | Lorna Gamboa VARIAN INC 25200 COMMERCENTRE DR. Lake Forest, CA 92630 -8810 |
| Product Code | DJC |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-06-09 |
| Summary: | summary |