The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Inorganic Phosphorus Reagent.
Device ID | K925057 |
510k Number | K925057 |
Device Name: | OLYMPUS INORGANIC PHOSPHORUS REAGENT |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-06 |
Decision Date | 1992-11-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590020118 | K925057 | 000 |
15099590010201 | K925057 | 000 |