IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material

FDA 510(k) Premarket Notification · Submission K143636 · Applicant: Siemens Healthcare Diagnostics, Inc.

Public Record 510(k) Submission Decision Date: 2015-02-25 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K143636.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K143636
Device Name
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
Product Code
JJX
Decision Date
2015-02-25
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Clinical Chemistry (CH)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2014-12-22

Related Establishments / Registrations

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