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510(k) K921958

ELISA TUBE TSH TEST by Bio Clinic Co. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1992
Date Received
April 27, 1992
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

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  • K920920 — ELISA TUBE LH TEST KIT (April 8, 1992)
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  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)
  • K920917 — ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (March 26, 1992)

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