The following data is part of a premarket notification filed by Technostics Intl. with the FDA for Direct & Total Bilirubin Set.
| Device ID | K855195 |
| 510k Number | K855195 |
| Device Name: | DIRECT & TOTAL BILIRUBIN SET |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Contact | Susan Renehan |
| Correspondent | Susan Renehan TECHNOSTICS INTL. P.O. BOX 94090 Washington, MI 48094 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-01-14 |