The following data is part of a premarket notification filed by Liberty Healthcare Group, Inc. with the FDA for Liberty Normal Glucose Control Solution.
| Device ID | K060706 |
| 510k Number | K060706 |
| Device Name: | LIBERTY NORMAL 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 | 2006-03-16 |
| Decision Date | 2006-04-28 |
| Summary: | summary |