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510(k) K842598

STAR HCG MONOCLONAL ANTIBODY IMMUNO by Syncor Intl. Corp. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1984
Date Received
June 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Syncor Intl. Corp.

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  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (August 21, 1985)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K851033 — SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (June 21, 1985)
  • K844735 — PTH-RIA (April 29, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)

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