The following data is part of a premarket notification filed by Reagent Laboratory, Inc. with the FDA for Solution B- Na 50meq/l, K 40 Meq/l.
| Device ID | K863502 |
| 510k Number | K863502 |
| Device Name: | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Contact | Donald Skaggs |
| Correspondent | Donald Skaggs REAGENT LABORATORY, INC. 300 EAST OTTAWA AVE. Louisville, KY 40209 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-21 |