The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Bm Precipath(r) Hdl/ldl-c Control.
| Device ID | K974826 |
| 510k Number | K974826 |
| Device Name: | BM PRECIPATH(R) HDL/LDL-C CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Edward R Kimmelman |
| Correspondent | Edward R Kimmelman BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-01-22 |
| Summary: | summary |