The following data is part of a premarket notification filed by Icl Scientific with the FDA for Rid System-quad Multitest Igg, Iga,etc..
Device ID | K800897 |
510k Number | K800897 |
Device Name: | RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. |
Classification | Igg, Antigen, Antiserum, Control |
Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DEW |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-18 |
Decision Date | 1980-05-08 |