Submission Details
| 510(k) Number | K100602 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 2010 |
| Decision Date | August 17, 2011 |
| Days to Decision | 532 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
Aug 2011
Decision
532d
Days
Class 1
Risk
About This 510(k) Submission
K100602 is an FDA 510(k) clearance for the NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on August 17, 2011, 532 days after receiving the submission on March 3, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.
Device Classification
| Product Code | KHP — Acid, Lactic, Enzymatic Method |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1450 |
Manufacturer
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