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FDA 510(k)

DS30 HCY HOMOCYSTEINE ASSAY KIT

K-Number: K982003 · 1999-02-11

ApplicantDrew Scientific , Ltd.
Decision Date1999-02-11
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DS30 HCY HOMOCYSTEINE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Drew Scientific , Ltd.. It received FDA 510(k) clearance on 1999-02-11 under 510(k) number K982003. 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 DS30 HCY HOMOCYSTEINE ASSAY KIT?

DS30 HCY HOMOCYSTEINE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1999-02-11. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K982003.

When did DS30 HCY HOMOCYSTEINE ASSAY KIT receive FDA 510(k) clearance?

DS30 HCY HOMOCYSTEINE ASSAY KIT received FDA 510(k) clearance on 1999-02-11, under 510(k) number K982003.

Who is the listed applicant for DS30 HCY HOMOCYSTEINE ASSAY KIT?

The FDA 510(k) record lists Drew Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DS30 HCY HOMOCYSTEINE ASSAY KIT?

The FDA product code for DS30 HCY HOMOCYSTEINE ASSAY KIT is LPS.

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Other records listing Drew Scientific , Ltd. 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.

K060510DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KITK043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITK012152DS30 HCY BLOOD COLLECTION TUBESK933287745 GLYCOMATK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK920198GLYCOMAT HAEMOGLOBIN ANALYSER

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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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