The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for Aso/crp/rf Controls For Immunoturbidimetric Assays.
Device ID | K983241 |
510k Number | K983241 |
Device Name: | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
Contact | Colin Getty |
Correspondent | Colin Getty KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-15 |
Decision Date | 1998-09-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816426020856 | K983241 | 000 |
00816426020849 | K983241 | 000 |