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510(k) K780792

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I by The Upjohn Co. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1978
Date Received
May 15, 1978
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 The Upjohn Co.

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  • K900455 — ZEFAZONE SUSCEPTIBILITY POWDER (February 9, 1990)
  • K810853 — CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT (May 29, 1981)
  • K782009 — RIA KIT, PROGESTERONE (March 2, 1979)
  • K760920 — CAT-A-KIT (November 9, 1976)

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