The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Dia Strips System.
Device ID | K831623 |
510k Number | K831623 |
Device Name: | DIA STRIPS SYSTEM |
Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
Applicant | CALIFORNIA IMMUNO DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CDM |
CFR Regulation Number | 862.1785 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-20 |
Decision Date | 1983-07-28 |