The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Lipase Linearity Control.
| Device ID | K913585 |
| 510k Number | K913585 |
| Device Name: | LIPASE LINEARITY CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Contact | Gary J Proksch |
| Correspondent | Gary J Proksch CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-12 |
| Decision Date | 1991-10-21 |