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FDA 510(k)

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

K-Number: K012518 · 2001-10-09

ApplicantThermo Dma, Inc.
Decision Date2001-10-09
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Dma, Inc.. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K012518. 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 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113?

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is Thermo Dma, Inc.. The 510(k) number is K012518.

When did TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 receive FDA 510(k) clearance?

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 received FDA 510(k) clearance on 2001-10-09, under 510(k) number K012518.

Who is the listed applicant for TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113?

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

What is the FDA product code for TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113?

The FDA product code for TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 is CJE.

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Other records listing Thermo Dma, Inc. 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.

K022108THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609K012525THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

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

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

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