The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for Liquid Immunology Controls For Immunoturbidimetric Assays.
| Device ID | K983130 |
| 510k Number | K983130 |
| Device Name: | LIQUID IMMUNOLOGY 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 | 1998-09-08 |
| Decision Date | 1998-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020825 | K983130 | 000 |
| 00816426020818 | K983130 | 000 |