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510(k) K873371

URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) by Bio-Rad — Product Code CHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
August 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic/Fluorometric Method, Catecholamines
Device Class
Class I
Regulation Number
862.1165
Review Panel
CH
Submission Type

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  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K894966 — PLASMA CATECHOLAMINES BY HPLC (October 25, 1989)
  • K855214 — CAT-3 CATECHOLAMINE ASSAY KIT (March 14, 1986)