Submission Details
| 510(k) Number | K122858 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2012 |
| Decision Date | October 03, 2012 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
Oct 2012
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K122858 is an FDA 510(k) clearance for the ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on October 3, 2012, 15 days after receiving the submission on September 18, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.
Device Classification
| Product Code | JFJ — Catalytic Methods, Amylase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1070 |
Manufacturer
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