The following data is part of a premarket notification filed by Diagnostic Specialties with the FDA for Enzip Urinary Microalbumin Test.
| Device ID | K922032 |
| 510k Number | K922032 |
| Device Name: | ENZIP URINARY MICROALBUMIN TEST |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Contact | Pagnucco |
| Correspondent | Pagnucco DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1992-07-30 |