The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Normal Lipid Control.
| Device ID | K895862 | 
| 510k Number | K895862 | 
| Device Name: | CLP NORMAL LIPID CONTROL | 
| Classification | Multi-analyte Controls, All Kinds (assayed) | 
| Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 | 
| Contact | Gary Proksch | 
| Correspondent | Gary Proksch CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 | 
| Product Code | JJY | 
| CFR Regulation Number | 862.1660 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1989-10-03 | 
| Decision Date | 1990-01-19 |