The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Unistat Bilirubinometer.
| Device ID | K781241 |
| 510k Number | K781241 |
| Device Name: | UNISTAT BILIRUBINOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-19 |
| Decision Date | 1978-08-14 |