The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Phosphorus Test.
Device ID | K811749 |
510k Number | K811749 |
Device Name: | KING DIAGNOSTICS PHOSPHORUS TEST |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-22 |
Decision Date | 1981-07-10 |