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 |