The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Calcheck Vitamin B12.
| Device ID | K974383 |
| 510k Number | K974383 |
| Device Name: | ELECSYS CALCHECK VITAMIN B12 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1997-12-08 |
| Summary: | summary |