The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for One Step Morphine Card Test.
| Device ID | K970579 |
| 510k Number | K970579 |
| Device Name: | ONE STEP MORPHINE CARD TEST |
| Classification | Thin Layer Chromatography, Morphine |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Andrew Reams |
| Correspondent | Andrew Reams TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | DNK |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1997-07-03 |