The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for B2-microglobulin Control Set Serum.
| Device ID | K982471 |
| 510k Number | K982471 |
| Device Name: | B2-MICROGLOBULIN CONTROL SET SERUM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Julie A Smith |
| Correspondent | Julie A Smith 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 | 1998-07-16 |
| Decision Date | 1998-08-06 |
| Summary: | summary |