The following data is part of a premarket notification filed by Innovacon, Inc. with the FDA for Innovacon Spectrum Ii Test Card.
| Device ID | K061718 |
| 510k Number | K061718 |
| Device Name: | INNOVACON SPECTRUM II TEST CARD |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-19 |
| Decision Date | 2006-11-13 |
| Summary: | summary |