The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Statstrip Lactate Hospital Meter System.
| Device ID | K112955 |
| 510k Number | K112955 |
| Device Name: | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2012-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480475549 | K112955 | 000 |
| 00385480475532 | K112955 | 000 |
| 00385480475525 | K112955 | 000 |
| 10385480474884 | K112955 | 000 |