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 |