The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Total Bilirubin Reagent Set.
| Device ID | K910635 |
| 510k Number | K910635 |
| Device Name: | TOTAL BILIRUBIN REAGENT SET |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
| Contact | Alejo V Roy |
| Correspondent | Alejo V Roy BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-05-15 |