The following data is part of a premarket notification filed by Medical Specialties Supply Co., Inc. with the FDA for Sms Multi Glucose Control, Model 2120049.
| Device ID | K070506 |
| 510k Number | K070506 |
| Device Name: | SMS MULTI GLUCOSE CONTROL, MODEL 2120049 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MEDICAL SPECIALTIES SUPPLY CO., INC. 1755 EAST BIRCHWOOD AVE. Des Plaines, IL 60018 |
| Contact | John C Gormley |
| Correspondent | John C Gormley MEDICAL SPECIALTIES SUPPLY CO., INC. 1755 EAST BIRCHWOOD AVE. Des Plaines, IL 60018 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-04-18 |
| Summary: | summary |