The following data is part of a premarket notification filed by Quantimetrix Medical Industries with the FDA for Quantimetrix Serum Alcohol Control Level 1 And 2.
| Device ID | K873011 |
| 510k Number | K873011 |
| Device Name: | QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 |
| Classification | Drug Specific Control Materials |
| Applicant | QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | Ernest S Johnson |
| Correspondent | Ernest S Johnson QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-10-29 |