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510(k) K030482

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 by Wiener Laboratories — Product Code JJY

K030482 is an FDA 510(k) premarket notification submitted by Wiener Laboratories for the device "WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553". The FDA issued a decision of Substantially Equivalent on March 19, 2003. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2003
Date Received
February 13, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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FDA data resources