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FDA 510(k), K990658, THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
FDA 510(k), K990658, THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
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510(K) Number: K990658
Device Name: THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
Manufacturer: JOEL R. L. EHRENKRANZ
Device Classification Name: Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation Number: JLW
Classification Product Code: KXA
Date Received: 03/01/1999
Decision Date: 06/02/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
Manufacturer: JOEL R. L. EHRENKRANZ
Device Classification Name: Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation Number: JLW
Classification Product Code: KXA
Date Received: 03/01/1999
Decision Date: 06/02/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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