The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Ultra L Analyzer Quality Control Materials.
| Device ID | K961938 |
| 510k Number | K961938 |
| Device Name: | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JPK |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-06-28 |