K112955 is an FDA 510(k) clearance for the NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 5, 2012, 93 days after receiving the submission on October 4, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K112955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2011 |
| Decision Date | January 05, 2012 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHP — Acid, Lactic, Enzymatic Method |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1450 |