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510(k) K952817

BIO-RAD URINARY 5-HIAA BY HPLC by Bio-Rad — Product Code CDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1995
Date Received
June 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device Class
Class I
Regulation Number
862.1390
Review Panel
CH
Submission Type

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Other clearances for product code CDA

  • K903609 — SEROTONIN ENZYME IMMUNOASSAY (October 22, 1990)
  • K854946 — TDXR 5-HIAA (URINE) (January 17, 1986)