The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Diazo, Colorimetric Bilirubin.
Device ID | K882459 |
510k Number | K882459 |
Device Name: | DIAZO, COLORIMETRIC BILIRUBIN |
Classification | Diazo Colorimetry, Bilirubin |
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 | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-15 |
Decision Date | 1988-08-02 |