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510(k) K801666

TESTOSTERONE KIT by Immuchem Corp. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
July 21, 1980
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

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  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K822509 — COVALENT COAT RIA KIT (September 28, 1982)
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