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510(k) K960195

THYROCHEK ONE-STEP RAPID TSH ASSAY by Franklin Diagnostics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Franklin Diagnostics, Inc.

  • K884612 — FRANKLIN COLLECTOR(R) (March 27, 1989)

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