The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Total Protein Reagent Set.
Device ID | K880677 |
510k Number | K880677 |
Device Name: | TOTAL PROTEIN REAGENT SET |
Classification | Biuret (colorimetric), Total Protein |
Applicant | TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
Contact | Arun Sanghavi |
Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago, IL 60632 |
Product Code | CEK |
CFR Regulation Number | 862.1635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-19 |
Decision Date | 1988-03-24 |