The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Special Control Serum For Hdl-choles.
| Device ID | K823196 |
| 510k Number | K823196 |
| Device Name: | SPECIAL CONTROL SERUM FOR HDL-CHOLES |
| Classification | Oncometer, Plasma, For Clinical Use |
| Applicant | BOEHRINGER MANNHEIM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJK |
| CFR Regulation Number | 862.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-26 |
| Decision Date | 1982-11-29 |