Cleared Traditional

K000887: DRX HBA1C

K000887 · Metrika, Inc. · Hematology

Jul 2000

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K000887 is an FDA 510(k) clearance for the DRX HBA1C, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 26, 2000, 128 days after receiving the submission on March 20, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K000887 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2000
Decision Date	July 26, 2000
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF