The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Statsensor Creatinine Hospital Meter, Control Solutions,linearity Solutions, And Test Strips.
| Device ID | K070068 |
| 510k Number | K070068 |
| Device Name: | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald,phd |
| Correspondent | Paul W Macdonald,phd NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-08 |
| Decision Date | 2007-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480506684 | K070068 | 000 |
| 10385480453353 | K070068 | 000 |
| 10385480440520 | K070068 | 000 |
| 00385480440370 | K070068 | 000 |
| 00385480439237 | K070068 | 000 |
| 00385480439220 | K070068 | 000 |
| 00385480439213 | K070068 | 000 |