The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Vitamin B12 Assay.
| Device ID | K973702 |
| 510k Number | K973702 |
| Device Name: | ELECSYS VITAMIN B12 ASSAY |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Yvette R Lloyd |
| Correspondent | Yvette R Lloyd BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1997-11-13 |
| Summary: | summary |