The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Calcium, Azo Dye Reagent.
Device ID | K040972 |
510k Number | K040972 |
Device Name: | CALCIUM, AZO DYE REAGENT |
Classification | Azo Dye, Calcium |
Applicant | GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea, CA 92821 |
Contact | C.c. Allain |
Correspondent | C.c. Allain GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea, CA 92821 |
Product Code | CJY |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-14 |
Decision Date | 2004-12-27 |
Summary: | summary |