The following data is part of a premarket notification filed by Liberty Healthcare Group, Inc. with the FDA for Liberty Glucose Control Solution.
Device ID | K060481 |
510k Number | K060481 |
Device Name: | LIBERTY GLUCOSE CONTROL SOLUTION |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | LIBERTY HEALTHCARE GROUP, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
Contact | John C Gormley |
Correspondent | John C Gormley LIBERTY HEALTHCARE GROUP, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-23 |
Decision Date | 2006-03-09 |
Summary: | summary |