The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Direct Bilirubin.
| Device ID | K860257 |
| 510k Number | K860257 |
| Device Name: | DIRECT BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | Janusz M Szyszko |
| Correspondent | Janusz M Szyszko POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-24 |
| Decision Date | 1986-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013866 | K860257 | 000 |
| 00811727013859 | K860257 | 000 |
| 00811727013842 | K860257 | 000 |
| 00811727010421 | K860257 | 000 |
| 00811727010414 | K860257 | 000 |
| 00811727010407 | K860257 | 000 |