The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Total Bilirubin Calibrators.
| Device ID | K855040 |
| 510k Number | K855040 |
| Device Name: | SERALYZER TOTAL BILIRUBIN CALIBRATORS |
| Classification | Calibrator, Primary |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John Engelmann |
| Correspondent | John Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-01-22 |