The following data is part of a premarket notification filed by Liberty Healthcare Group, Inc. with the FDA for Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047.
| Device ID | K063855 |
| 510k Number | K063855 |
| Device Name: | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 |
| 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 | 2006-12-28 |
| Decision Date | 2007-02-01 |
| Summary: | summary |