Submission Details
| 510(k) Number | K162538 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2016 |
| Decision Date | November 17, 2016 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Nov 2016
Decision
66d
Days
Class 2
Risk
About This 510(k) Submission
K162538 is an FDA 510(k) clearance for the ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Siemens Healthcare Diagnostics (East Walpole, US). The FDA issued a Cleared decision on November 17, 2016, 66 days after receiving the submission on September 12, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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