The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Calibrators, Control Materials, Electrodes & Tube.
| Device ID | K897177 |
| 510k Number | K897177 |
| Device Name: | CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-03-27 |