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FDA 510(k)

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

K-Number: K924496 · 1992-11-16

ApplicantDrew Scientific , Ltd.
Decision Date1992-11-16
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT 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 1992-11-16 under 510(k) number K924496. The device is classified under product code JPD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT?

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K924496.

When did GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT receive FDA 510(k) clearance?

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT received FDA 510(k) clearance on 1992-11-16, under 510(k) number K924496.

Who is the listed applicant for GLYCOMAT GREEN HBA2 ESTIMATION REAGENT 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 GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT?

The FDA product code for GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT is JPD.

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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 GLYCOMATK920198GLYCOMAT HAEMOGLOBIN ANALYSER

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Related Devices (Code: JPD)

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.

K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.K991127VARIANT II B-THALASSEMIABio-RadK924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-RadK923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena LaboratoriesK923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena LaboratoriesK913384COLUMNMATE(TM) BETA-THAL CAT. NO. 4515Helena Laboratories

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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