The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Triglycerides Gpo Without Free Glycerol.
| Device ID | K873049 |
| 510k Number | K873049 |
| Device Name: | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Cheri Emmons |
| Correspondent | Cheri Emmons BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630992362 | K873049 | 000 |
| 04015630928125 | K873049 | 000 |
| 04015630925117 | K873049 | 000 |
| 04015630921959 | K873049 | 000 |
| 04015630918393 | K873049 | 000 |