The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Alkphor System.
Device ID | K823445 |
510k Number | K823445 |
Device Name: | ALKPHOR SYSTEM |
Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
Applicant | CALIFORNIA IMMUNO DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIN |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-16 |
Decision Date | 1982-12-28 |