The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Uric Acid Reagent Set.
Device ID | K880277 |
510k Number | K880277 |
Device Name: | URIC ACID REAGENT SET |
Classification | Acid, Uric, Uricase (colorimetric) |
Applicant | TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
Contact | Arun Sanghavi |
Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
Product Code | KNK |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-21 |
Decision Date | 1988-04-18 |