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 |