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FDA 510(k)

TECO HOMOCYSTEINE ENZYMATIC ASSAY

K-Number: K063701 · 2007-04-11

ApplicantTeco Diagnostics
Decision Date2007-04-11
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECO HOMOCYSTEINE ENZYMATIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2007-04-11 under 510(k) number K063701. The device is classified under product code LPS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECO HOMOCYSTEINE ENZYMATIC ASSAY?

TECO HOMOCYSTEINE ENZYMATIC ASSAY is a medical device that received FDA 510(k) clearance on 2007-04-11. The listed applicant is Teco Diagnostics. The 510(k) number is K063701.

When did TECO HOMOCYSTEINE ENZYMATIC ASSAY receive FDA 510(k) clearance?

TECO HOMOCYSTEINE ENZYMATIC ASSAY received FDA 510(k) clearance on 2007-04-11, under 510(k) number K063701.

Who is the listed applicant for TECO HOMOCYSTEINE ENZYMATIC ASSAY?

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

What is the FDA product code for TECO HOMOCYSTEINE ENZYMATIC ASSAY?

The FDA product code for TECO HOMOCYSTEINE ENZYMATIC ASSAY is LPS.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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Related Devices (Code: LPS)

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.

K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K121053DIAZYME HOMOCYSTEINE POC TEST KITDiazyme LaboratoriesK121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.K113793HOMOCYSTEINE TESTRocheK112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.

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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