The following data is part of a premarket notification filed by Diagnostic Specialties with the FDA for Enzip Immunoturbidimetric Microalbumin Assay Kit.
| Device ID | K971458 |
| 510k Number | K971458 |
| Device Name: | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Contact | Rinaldo Pagnucco |
| Correspondent | Rinaldo Pagnucco DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Product Code | JIQ |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-22 |
| Decision Date | 1997-09-02 |