The following data is part of a premarket notification filed by Bio-reagents & Diagnostics, Inc. with the FDA for Calibrator, Bovine Serum.
| Device ID | K781702 |
| 510k Number | K781702 |
| Device Name: | CALIBRATOR, BOVINE SERUM |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BIO-REAGENTS & DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-10 |
| Decision Date | 1978-11-15 |