The following data is part of a premarket notification filed by Maruzen Petrochemical Co., Ltd. with the FDA for Lumico Analyzer Sa-300.
| Device ID | K923158 |
| 510k Number | K923158 |
| Device Name: | LUMICO ANALYZER SA-300 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | MARUZEN PETROCHEMICAL CO., LTD. 25-10 HATCHOBORI 2 CHOME CHUO-KU, TOKYO 104 Japan, JP |
| Contact | Kinya Fujii |
| Correspondent | Kinya Fujii MARUZEN PETROCHEMICAL CO., LTD. 25-10 HATCHOBORI 2 CHOME CHUO-KU, TOKYO 104 Japan, JP |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-11-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUMICO ANALYZER SA-300 74224454 not registered Dead/Abandoned |
Maruzen Petrochemical Co., Ltd. 1991-11-22 |