The following data is part of a premarket notification filed by Integrated Biomedical Technology, Inc. with the FDA for High Range Peroxide Test Strip.
| Device ID | K964264 |
| 510k Number | K964264 |
| Device Name: | HIGH RANGE PEROXIDE TEST STRIP |
| Classification | System, Dialysate Delivery, Single Patient |
| 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 | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G212HP20401 | K964264 | 000 |