The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Sera Aris Pheno Reag Strip, Test Mod Cal & Clt.
| Device ID | K852946 |
| 510k Number | K852946 |
| Device Name: | SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT |
| Classification | Enzyme Immunoassay, Phenobarbital |
| 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 | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-11 |
| Decision Date | 1985-09-30 |