Medical Device Manufacturer · GB , London W4 4ph Uk

Drew Scientific , Ltd.

7 submissions · 7 cleared · Since 1992

Total

Cleared

Denied

Drew Scientific , Ltd. — FDA 510(k) Submissions

Drew Scientific , Ltd. has submitted 7 FDA 510(k) premarket notifications since 1992, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Calibrator, Secondary, Single (specified) Analyte Controls (assayed And Unassayed), Hemoglobin A2 Quantitation, Urinary Homocystine (nonquantitative) Test System . Use the specialty filter in the sidebar to narrow results.

7 devices

1–7 of 7

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

K060510 · JJX Single (specified)... · Chemistry

Jun 2006 112d

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

K043378 · JIT Calibrator, Secondary · Chemistry

Dec 2004 21d

DS30 HCY BLOOD COLLECTION TUBES

K012152 · GIM Tubes, Vacuum Sample,... · Chemistry

Sep 2001 69d

DS30 HCY HOMOCYSTEINE ASSAY KIT

K982003 · LPS Urinary Homocystine... · Hematology

Feb 1999 248d

745 GLYCOMAT

K933287 · LCP Assay, Glycosylated... · Hematology

Sep 1993 65d

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

K924496 · JPD Hemoglobin A2 Quantitation · Hematology

Nov 1992 73d

GLYCOMAT HAEMOGLOBIN ANALYSER

K920198 · LCP Assay, Glycosylated... · Hematology

Jul 1992 188d

Drew Scientific , Ltd.

Drew Scientific , Ltd. — FDA 510(k) Submissions

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