The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Total Bilirubin Reagent Set.
| Device ID | K040391 |
| 510k Number | K040391 |
| Device Name: | TOTAL BILIRUBIN REAGENT SET |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014962 | K040391 | 000 |
| 00811727016133 | K040391 | 000 |
| 00811727016256 | K040391 | 000 |
| 00811727012579 | K040391 | 000 |
| 00811727012586 | K040391 | 000 |
| 00811727012937 | K040391 | 000 |
| 00811727012944 | K040391 | 000 |
| 00811727013576 | K040391 | 000 |
| 00811727013583 | K040391 | 000 |
| 00811727014665 | K040391 | 000 |
| 00811727014672 | K040391 | 000 |
| 00811727014948 | K040391 | 000 |
| 00811727015952 | K040391 | 000 |