The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Uric-acid Test Enzymatic Colorimetric.
Device ID | K831864 |
510k Number | K831864 |
Device Name: | URIC-ACID TEST ENZYMATIC COLORIMETRIC |
Classification | Acid, Uric, Uricase (colorimetric) |
Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNK |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-10 |
Decision Date | 1983-07-22 |