The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Bl Bilirubinometer.
| Device ID | K790608 |
| 510k Number | K790608 |
| Device Name: | BL BILIRUBINOMETER |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ADVANCED INSTRUMENTS, INC. SHORASHIM |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-29 |
| Decision Date | 1979-06-15 |