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FDA 510(k)

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

K-Number: K011692 · 2001-07-25

ApplicantIntersect Systems, Inc.
Decision Date2001-07-25
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 2001-07-25 under 510(k) number K011692. 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 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT?

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT is a medical device that received FDA 510(k) clearance on 2001-07-25. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K011692.

When did HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT receive FDA 510(k) clearance?

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT received FDA 510(k) clearance on 2001-07-25, under 510(k) number K011692.

Who is the listed applicant for HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT?

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

What is the FDA product code for HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT?

The FDA product code for HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT is LPS.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENTK941807INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

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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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