The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Calcium (az Iii) Reagent.
Device ID | K922835 |
510k Number | K922835 |
Device Name: | CALCIUM (AZ III) REAGENT |
Classification | Azo Dye, Calcium |
Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Contact | Frances Loh |
Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Product Code | CJY |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-12 |
Decision Date | 1992-08-04 |