The following data is part of a premarket notification filed by Quantimetrix Medical Industries with the FDA for Quantimetrix Bilirubin Calibrators.
| Device ID | K895778 |
| 510k Number | K895778 |
| Device Name: | QUANTIMETRIX BILIRUBIN CALIBRATORS |
| Classification | Calibrator, Primary |
| Applicant | QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | P Tarburton,phd |
| Correspondent | P Tarburton,phd QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-27 |
| Decision Date | 1989-11-14 |