The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Vitamin B12 Fluorometric Enzyme-linked.
| Device ID | K924074 |
| 510k Number | K924074 |
| Device Name: | STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Nancy A Hornbaker |
| Correspondent | Nancy A Hornbaker BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1992-10-26 |