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FDA 510(k)

BIO-RAD HOMOCYSTEINE BY HPLC

K-Number: K993107 · 1999-12-21

ApplicantBio-Rad
Decision Date1999-12-21
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD HOMOCYSTEINE BY HPLC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K993107. 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 BIO-RAD HOMOCYSTEINE BY HPLC?

BIO-RAD HOMOCYSTEINE BY HPLC is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Bio-Rad. The 510(k) number is K993107.

When did BIO-RAD HOMOCYSTEINE BY HPLC receive FDA 510(k) clearance?

BIO-RAD HOMOCYSTEINE BY HPLC received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993107.

Who is the listed applicant for BIO-RAD HOMOCYSTEINE BY HPLC?

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

What is the FDA product code for BIO-RAD HOMOCYSTEINE BY HPLC?

The FDA product code for BIO-RAD HOMOCYSTEINE BY HPLC is LPS.

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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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