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510(k) K860130

TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT by Cambridge Medical Technology — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1986
Date Received
January 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

Other clearances by Cambridge Medical Technology

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  • K873737 — NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (November 24, 1987)
  • K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (April 22, 1987)
  • K862871 — RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL (August 19, 1986)
  • K855169 — T3 UPTAKE RADIOIMMUNOASSAY KIT (February 6, 1986)
  • K850254 — PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (April 3, 1985)
  • K843635 — MATCHED COMPONENT SET FOR RADIOIMMUNO- (September 28, 1984)
  • K841042 — MATCHED COMPONENT SET RADIOIMMUNOASSAY (April 19, 1984)

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