The following data is part of a premarket notification filed by Quantimetrix Medical Industries with the FDA for Quantimetrix Urine Drugs Of Abuse Control.
| Device ID | K873467 |
| 510k Number | K873467 |
| Device Name: | QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | Johnson, Iii |
| Correspondent | Johnson, Iii QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-28 |
| Decision Date | 1987-09-29 |