The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Diazo Colorimetry, Billirubin.
| Device ID | K832870 |
| 510k Number | K832870 |
| Device Name: | DIAZO COLORIMETRY, BILLIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-25 |
| Decision Date | 1983-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013934 | K832870 | 000 |
| 00811727013927 | K832870 | 000 |
| 00811727013910 | K832870 | 000 |
| 00811727010452 | K832870 | 000 |
| 00811727010445 | K832870 | 000 |
| 00811727010438 | K832870 | 000 |
| 00817439021250 | K832870 | 000 |
| 00817439021243 | K832870 | 000 |
| 00817439021236 | K832870 | 000 |