The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Single Vial Lipase Test Kit.
| Device ID | K802842 |
| 510k Number | K802842 |
| Device Name: | SINGLE VIAL LIPASE TEST KIT |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | BIODYNAMICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1980-12-18 |