K130113 is an FDA 510(k) clearance for the PICCOLO LACTATE TEST SYSTEM. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on March 11, 2013, 54 days after receiving the submission on January 16, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K130113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2013 |
| Decision Date | March 11, 2013 |
| Days to Decision | 54 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 |