The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Urinary Albumin Calibrator.
| Device ID | K936201 |
| 510k Number | K936201 |
| Device Name: | URINARY ALBUMIN CALIBRATOR |
| Classification | Calibrator, Primary |
| Applicant | DUPONT MEDICAL PRODUCTS 331 TREBLE COVE RD. N. Billerica, MA 01862 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS 331 TREBLE COVE RD. N. Billerica, MA 01862 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-03-11 |