INVIEW

Assay, Glycosylated Hemoglobin

METRIKA, INC.

The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for Inview.

Pre-market Notification Details

• Device ID: K051321
• 510k Number: K051321
• Device Name: INVIEW
• Classification: Assay, Glycosylated Hemoglobin
• Applicant: METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022
• Contact: Erika B Ammirati
• Correspondent: Erika B Ammirati; METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022
• Product Code: LCP
• CFR Regulation Number: 864.7470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-05-20
• Decision Date: 2005-06-13