Medical Device Manufacturer · US , Sunnyvale , CA

Metrika, Inc.

11 submissions · 11 cleared · Since 1999
11
Total
11
Cleared
0
Denied

Metrika, Inc. — FDA 510(k) Submissions

Metrika, Inc. has submitted 11 FDA 510(k) premarket notifications since 1999, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, System, Test, Human Chorionic Gonadotropin, Urinalysis Controls (assayed And Unassayed), Column Chromatography & Color Development, Hydroxyproline, Enzymatic Method, Creatinine . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
INVIEW
K051321 · LCP Assay, Glycosylated... · Chemistry
Jun 2005 24d
A1CNOW FOR HOME AND PROFESSIONAL USE
K033847 · LCP Assay, Glycosylated... · Chemistry
Dec 2003 12d
A1CNOW FOR HOME USE
K022661 · LCP Assay, Glycosylated... · Hematology
Dec 2002 126d
A1CNOW FOR RX HOME USE
K020234 · LCP Assay, Glycosylated... · Hematology
Feb 2002 23d
A1CNOW FOR PROFESSIONAL USE
K020235 · LCP Assay, Glycosylated... · Hematology
Feb 2002 23d
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885 · LCP Assay, Glycosylated... · Hematology
Sep 2000 190d
DRX HBA1C
K000887 · LCP Assay, Glycosylated... · Hematology
Jul 2000 128d
OSTEOMARK NTX POC
K992997 · JMM Column Chromatography &... · Chemistry
Nov 1999 63d
DRX QT. HCG
K991532 · DHA System, Test, Human... · Chemistry
Sep 1999 137d
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
K984530 · JFY Enzymatic Method, Creatinine · Chemistry
Aug 1999 232d
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
K991917 · JJW Urinalysis Controls... · Chemistry
Jul 1999 35d
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