The following data is part of a premarket notification filed by Integrated Biomedical Technology, Inc. with the FDA for Glutartest 1 Reagent Strip.
| Device ID | K002011 |
| 510k Number | K002011 |
| Device Name: | GLUTARTEST 1 REAGENT STRIP |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | INTEGRATED BIOMEDICAL TECHNOLOGY, INC. 2931 MOOSE TRAIL Elkhart, IN 46514 |
| Contact | Wen H Wu |
| Correspondent | Wen H Wu INTEGRATED BIOMEDICAL TECHNOLOGY, INC. 2931 MOOSE TRAIL Elkhart, IN 46514 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2001-01-22 |