Submission Details
| 510(k) Number | K113216 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
RAPIDPOINT 500 BLOOD GAS ANALYER
May 2012
Decision
184d
Days
Class 1
Risk
About This 510(k) Submission
K113216 is an FDA 510(k) clearance for the RAPIDPOINT 500 BLOOD GAS ANALYER, 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 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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