The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile 8 Analyzer,calibrators And Materials.
| Device ID | K905264 |
| 510k Number | K905264 |
| Device Name: | STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-21 |
| Decision Date | 1991-03-05 |