The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Photometer, Serometer (model 380).
| Device ID | K760395 |
| 510k Number | K760395 |
| Device Name: | PHOTOMETER, SEROMETER (MODEL 380) |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | MALLINCKRODT CRITICAL CARE 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 | 1976-08-06 |
| Decision Date | 1976-11-01 |