The following data is part of a premarket notification filed by Medical Diagnostics, Ca. with the FDA for Mdi Quik Test Narcotics Drug Screen.
| Device ID | K853140 |
| 510k Number | K853140 |
| Device Name: | MDI QUIK TEST NARCOTICS DRUG SCREEN |
| Classification | Thin Layer Chromatography, Morphine |
| Applicant | MEDICAL DIAGNOSTICS, CA. 9062 ROUTE 108 Columbia, MD 21045 |
| Contact | Frank 0 Holcombe |
| Correspondent | Frank 0 Holcombe MEDICAL DIAGNOSTICS, CA. 9062 ROUTE 108 Columbia, MD 21045 |
| Product Code | DNK |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-29 |
| Decision Date | 1986-03-03 |