The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Lipase Reagent.
| Device ID | K963424 |
| 510k Number | K963424 |
| Device Name: | OLYMPUS LIPASE REAGENT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590020149 | K963424 | 000 |
| 15099590010270 | K963424 | 000 |