The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Aris Carbamazepine Strips/modu/cali/cont.
| Device ID | K863842 |
| 510k Number | K863842 |
| Device Name: | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT |
| Classification | Enzyme Immunoassay, Carbamazepine |
| 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 | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-01 |
| Decision Date | 1987-01-14 |