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FDA 510(k)

GLYCOMAT HAEMOGLOBIN ANALYSER

K-Number: K920198 · 1992-07-21

ApplicantDrew Scientific , Ltd.
Decision Date1992-07-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOMAT HAEMOGLOBIN ANALYSER 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 1992-07-21 under 510(k) number K920198. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOMAT HAEMOGLOBIN ANALYSER?

GLYCOMAT HAEMOGLOBIN ANALYSER is a medical device that received FDA 510(k) clearance on 1992-07-21. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K920198.

When did GLYCOMAT HAEMOGLOBIN ANALYSER receive FDA 510(k) clearance?

GLYCOMAT HAEMOGLOBIN ANALYSER received FDA 510(k) clearance on 1992-07-21, under 510(k) number K920198.

Who is the listed applicant for GLYCOMAT HAEMOGLOBIN ANALYSER?

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 GLYCOMAT HAEMOGLOBIN ANALYSER?

The FDA product code for GLYCOMAT HAEMOGLOBIN ANALYSER is LCP.

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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 TUBESK982003DS30 HCY HOMOCYSTEINE ASSAY KITK933287745 GLYCOMATK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

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Related Devices (Code: LCP)

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.

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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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