The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Ip Acid Reagent Ip Moly Bdate Reagent.
Device ID | K852003 |
510k Number | K852003 |
Device Name: | IP ACID REAGENT IP MOLY BDATE REAGENT |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
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 | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-07 |
Decision Date | 1985-05-31 |