The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Tgl Flex Reagent Cartridge.
| Device ID | K010871 |
| 510k Number | K010871 |
| Device Name: | TGL FLEX REAGENT CARTRIDGE |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005657 | K010871 | 000 |