The following data is part of a premarket notification filed by Reagent Laboratory, Inc. with the FDA for Urine Diluent-for Use With Ion Selective Electrode.
| Device ID | K860143 |
| 510k Number | K860143 |
| Device Name: | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE |
| Classification | Electrode, Ion Selective (non-specified) |
| Applicant | REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Contact | Don Skaggs |
| Correspondent | Don Skaggs REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Product Code | JJP |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-15 |
| Decision Date | 1986-02-10 |