The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Urinary Protein Analytical Test Pack.
| Device ID | K822231 |
| 510k Number | K822231 |
| Device Name: | ACA URINARY PROTEIN ANALYTICAL TEST PACK |
| Classification | Turbidimetric, Total Protein |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-09-30 |