The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Potassium Reagent Strips, Test Module, &.
| Device ID | K844955 |
| 510k Number | K844955 |
| Device Name: | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John H Engelmann |
| Correspondent | John H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-21 |
| Decision Date | 1985-03-19 |