The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay C3.
Device ID | K993437 |
510k Number | K993437 |
Device Name: | K-ASSAY C3 |
Classification | Complement C3, Antigen, Antiserum, Control |
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 | CZW |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-12 |
Decision Date | 1999-11-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816426020078 | K993437 | 000 |