K951331 is an FDA 510(k) clearance for the ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 11, 1995, 140 days after receiving the submission on March 24, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K951331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1995 |
| Decision Date | August 11, 1995 |
| Days to Decision | 140 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 |