The following data is part of a premarket notification filed by Environmental Chemical Specialties with the FDA for Quantitative Control Urine I (human).
| Device ID | K792374 |
| 510k Number | K792374 |
| Device Name: | QUANTITATIVE CONTROL URINE I (HUMAN) |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | ENVIRONMENTAL CHEMICAL SPECIALTIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-26 |
| Decision Date | 1979-12-06 |