The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Albumin Screen Test.
| Device ID | K870516 |
| 510k Number | K870516 |
| Device Name: | ALBUMIN SCREEN TEST |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | JIQ |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-04 |
| Decision Date | 1987-10-20 |