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510(k) K851329

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA by Corning Medical & Scientific — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
April 4, 1985
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 Corning Medical & Scientific

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  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (November 26, 1985)
  • K853634 — CORNING CELL WELLS-MULTIPLE WELL PLATES (September 16, 1985)
  • K851939 — CORNING CERTAIN -ISE (June 14, 1985)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)

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