Submission Details
| 510(k) Number | K150031 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2015 |
| Decision Date | October 01, 2015 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
hemoFISH Masterpanel
Oct 2015
Decision
266d
Days
Class 1
Risk
About This 510(k) Submission
K150031 is an FDA 510(k) clearance for the hemoFISH Masterpanel, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Miacom Diagnostics GmbH (Dusseldorf, DE). The FDA issued a Cleared decision on October 1, 2015, 266 days after receiving the submission on January 8, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.
Device Classification
| Product Code | JSS — Kit, Identification, Enterobacteriaceae |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2660 |
Manufacturer
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