The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Inorganic Phosphorus Reagent.
Device ID | K955937 |
510k Number | K955937 |
Device Name: | INORGANIC PHOSPHORUS REAGENT |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
Contact | Charles C Allain |
Correspondent | Charles C Allain DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-21 |
Decision Date | 1996-03-12 |