The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Sychron(tm) Triglycerides Reagent.
| Device ID | K915084 |
| 510k Number | K915084 |
| Device Name: | BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1992-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233228 | K915084 | 000 |