Submission Details
| 510(k) Number | K150132 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 21, 2015 |
| Decision Date | April 13, 2015 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Apr 2015
Decision
82d
Days
Class 1
Risk
About This 510(k) Submission
K150132 is an FDA 510(k) clearance for the IMMULITE IGF Control Module, IMMULITE Gastrin Control Module, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on April 13, 2015, 82 days after receiving the submission on January 21, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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