The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Modified Saltex Reagent Strips.
| Device ID | K870214 |
| 510k Number | K870214 |
| Device Name: | MODIFIED SALTEX REAGENT STRIPS |
| Classification | Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride |
| 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 | CHK |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-20 |
| Decision Date | 1987-06-29 |