Inview

FDA 510(k) K051321 · Metrika, Inc.

Substantially Equivalent

510(k) numberK051321

Submission

Device name
Inview
Applicant
Metrika, Inc.
Sunnyvale, CA, US
Received
May 20, 2005
Decision date
June 13, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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More from Alfa Wassermann Diagnostic Technologies, LLC

510(k)DeviceDecision
K033847A1CNOW for Home and Professional UseLCP · Special 12/23/2003SE
K022661A1CNOW for Home UseLCP · Traditional 12/13/2002SE
K020235A1CNOW for Professional UseLCP · Special 02/15/2002SE
K020234A1CNOW for RX Home UseLCP · Special 02/15/2002SE
K000885DRX HBA1C - for Prescription Home UseLCP · Traditional 09/26/2000SE
K000887DRX HBA1CLCP · Traditional 07/26/2000SE
K992997Osteomark NTX PocJMM · Traditional 11/09/1999SE
K991532DRX Qt. HCGDHA · Traditional 09/17/1999SE
K984530DRX NTX or, Osteomark NTX Direct ResponseJFY · Traditional 08/10/1999SE
K991917Osteomark NTX Point of Care (Poc) Control SetJJW · Traditional 07/12/1999SE

Questions and answers

When was Inview cleared by the FDA?

Inview (K051321) received a 510(k) decision of Substantially Equivalent on June 13, 2005, 24 days after the submission was received.

What is the product code of K051321?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.