The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Double Antibody Albumin For Detect Microalbuminuri.
| Device ID | K851338 |
| 510k Number | K851338 |
| Device Name: | DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Sidney A Aroesty |
| Correspondent | Sidney A Aroesty DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1986-04-07 |