The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Inorganic Phosphorus Assay Kit.
Device ID | K843030 |
510k Number | K843030 |
Device Name: | INORGANIC PHOSPHORUS ASSAY KIT |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-01 |
Decision Date | 1984-08-27 |