The following data is part of a premarket notification filed by Reprocessing Products Corp. with the FDA for Micro X Residual Test Strips.
| Device ID | K974064 |
| 510k Number | K974064 |
| Device Name: | MICRO X RESIDUAL TEST STRIPS |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. Maple Grove, MN 55311 |
| Contact | Walter Jansen |
| Correspondent | Walter Jansen REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. Maple Grove, MN 55311 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1998-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858293006113 | K974064 | 000 |