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510(k) K162514

Multichem A1c by Technopath Manufacturing — Product Code JJX

K162514 is an FDA 510(k) premarket notification submitted by Technopath Manufacturing for the device "Multichem A1c". The FDA issued a decision of Substantially Equivalent on October 26, 2016. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2016
Date Received
September 8, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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FDA data resources