FDA 510(k)

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

K-Number: K130765 · 2013-04-04

Decision Date2013-04-04

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2013-04-04 under 510(k) number K130765. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II is a medical device that received FDA 510(k) clearance on 2013-04-04. The listed applicant is Elitechgroup. The 510(k) number is K130765.

When did ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II receive FDA 510(k) clearance?

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II received FDA 510(k) clearance on 2013-04-04, under 510(k) number K130765.

Who is the listed applicant for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

The FDA 510(k) record lists Elitechgroup as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

The FDA product code for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II is JIX.

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Other records listing Elitechgroup as applicant

K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGenius K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II K122177ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II K122083ELITECH CLINICAL SYSTEMS CK NAC SL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.