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510(k) K854876

ALDOSTERONE DIRECT RIA KIT by Biotecx Laboratories, Inc. — Product Code KQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1986
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Angiotensin Converting Enzyme
Device Class
Class II
Regulation Number
862.1090
Review Panel
CH
Submission Type

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  • K863188 — HPL RIA KIT (September 25, 1986)
  • K851540 — ESTRADIOL DIRECT RIA KIT (June 6, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)

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