FDA 510(k)

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

K-Number: K111996 · 2011-09-14

Decision Date2011-09-14

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2011-09-14 under 510(k) number K111996. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2?

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 is a medical device that received FDA 510(k) clearance on 2011-09-14. The listed applicant is Elitechgroup. The 510(k) number is K111996.

When did ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 receive FDA 510(k) clearance?

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 received FDA 510(k) clearance on 2011-09-14, under 510(k) number K111996.

Who is the listed applicant for ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2?

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 SYSEMS ISE CONTROL 1 AND 2?

The FDA product code for ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 is JJY.

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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 K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS 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

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Related Devices (Code: JJY)

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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.