FDA 510(k) Premarket Notification K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

Submission Details & Decision

Normalized public record details for 510(k) notification K151792.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K151792

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

Product Code

JLW

Decision Date

2015-11-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2015-07-01

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