The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Iii Blood Chemistry Analyzer.
| Device ID | K872120 |
| 510k Number | K872120 |
| Device Name: | SERALYZER III BLOOD CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | H Engelmann |
| Correspondent | H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-10-28 |