The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Albumin Test.
Device ID | K811662 |
510k Number | K811662 |
Device Name: | ALBUMIN TEST |
Classification | Bromcresol Green Dye-binding, Albumin |
Applicant | KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIX |
CFR Regulation Number | 862.1035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-15 |
Decision Date | 1981-06-25 |