The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Bilirubinometer.
| Device ID | K811840 |
| 510k Number | K811840 |
| Device Name: | BILIRUBINOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ADVANCED INSTRUMENTS, INC. SHORASHIM |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-15 |