The following data is part of a premarket notification filed by American Biological Technologies, Inc. with the FDA for Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087.
| Device ID | K091460 |
| 510k Number | K091460 |
| Device Name: | ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AMERICAN BIOLOGICAL TECHNOLOGIES, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
| Contact | John Gormley |
| Correspondent | John Gormley AMERICAN BIOLOGICAL TECHNOLOGIES, 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 | 2009-05-18 |
| Decision Date | 2009-08-06 |
| Summary: | summary |