The following data is part of a premarket notification filed by Axis-shield Biochemicals, Asa with the FDA for Bio-rad %cdt Tia.
| Device ID | K001651 |
| 510k Number | K001651 |
| Device Name: | BIO-RAD %CDT TIA |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AXIS-SHIELD BIOCHEMICALS, ASA P.O. BOX 262069 San Diego, CA 92196 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi AXIS-SHIELD BIOCHEMICALS, ASA P.O. BOX 262069 San Diego, CA 92196 |
| Product Code | JJX |
| Subsequent Product Code | JIS |
| Subsequent Product Code | NAO |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-30 |
| Decision Date | 2000-11-22 |