The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Phosphorus Test (phos).
Device ID | K945368 |
510k Number | K945368 |
Device Name: | PHOSPHORUS TEST (PHOS) |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Contact | Carol Faulkner |
Correspondent | Carol Faulkner EMD CHEMICALS INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-20 |
Decision Date | 1994-12-02 |