The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Mg Reagent.
Device ID | K852005 |
510k Number | K852005 |
Device Name: | MG REAGENT |
Classification | Photometric Method, Magnesium |
Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
Contact | Yosip F Warda |
Correspondent | Yosip F Warda ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-07 |
Decision Date | 1985-06-25 |