The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips.
| Device ID | K100602 |
| 510k Number | K100602 |
| Device Name: | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS |
| Classification | Acid, Lactic, Enzymatic Method |
| 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 | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2011-08-17 |
| Summary: | summary |