The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Creatinine Reagent Set (kinetic).
Device ID | K880843 |
510k Number | K880843 |
Device Name: | CREATININE REAGENT SET (KINETIC) |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
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 | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-04-05 |