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FDA 510(k)

ELITTECH CLINICAL SYSTEMS ALP IFCC SL

K-Number: K113269 · 2011-12-29

ApplicantElitechgroup
Decision Date2011-12-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELITTECH CLINICAL SYSTEMS ALP IFCC SL is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2011-12-29 under 510(k) number K113269. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

ELITTECH CLINICAL SYSTEMS ALP IFCC SL is a medical device that received FDA 510(k) clearance on 2011-12-29. The listed applicant is Elitechgroup. The 510(k) number is K113269.

When did ELITTECH CLINICAL SYSTEMS ALP IFCC SL receive FDA 510(k) clearance?

ELITTECH CLINICAL SYSTEMS ALP IFCC SL received FDA 510(k) clearance on 2011-12-29, under 510(k) number K113269.

Who is the listed applicant for ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

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 ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

The FDA product code for ELITTECH CLINICAL SYSTEMS ALP IFCC SL is CJE.

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Other records listing Elitechgroup as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusK171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIK122177ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVELK122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

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Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

Official Source

View on FDA Database →

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

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