K113216 is an FDA 510(k) clearance for the RAPIDPOINT 500 BLOOD GAS ANALYER. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on May 3, 2012, 184 days after receiving the submission on November 1, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K113216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | May 03, 2012 |
| Days to Decision | 184 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 |