The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Aris Phenytoin Reagent Strips.
| Device ID | K842092 |
| 510k Number | K842092 |
| Device Name: | SERALYZER ARIS PHENYTOIN REAGENT STRIPS |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | MILES LABORATORIES, INC. P.O. BOX 40 Elkhart, IN 46515 |
| Contact | H Engelmann |
| Correspondent | H Engelmann MILES LABORATORIES, INC. P.O. BOX 40 Elkhart, IN 46515 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-24 |
| Decision Date | 1985-03-19 |