Bio-Rad Urinary 5-HIAA by HPLC

FDA 510(k) K952817 · Bio-Rad

Substantially Equivalent

510(k) numberK952817

Submission

Device name
Bio-Rad Urinary 5-HIAA by HPLC
Applicant
Bio-Rad
Hercules, CA, US
Received
June 20, 1995
Decision date
August 1, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CDA – Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device class
Class I (low risk)
Regulation
21 CFR 862.1390
Specialty
Clinical Chemistry

Other 510(k)s with product code CDA

510(k)DeviceApplicantDecision
K903609Serotonin Enzyme ImmunoassayCDA · Traditional Immunotech Corp.10/22/1990SE
K854946TDXR 5-HIAA (Urine)CDA · Traditional Abbott Laboratories01/17/1986SE

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Questions and answers

When was Bio-Rad Urinary 5-HIAA by HPLC cleared by the FDA?

Bio-Rad Urinary 5-HIAA by HPLC (K952817) received a 510(k) decision of Substantially Equivalent on August 1, 1995, 42 days after the submission was received.

What is the product code of K952817?

The FDA product code is CDA – Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin, a Class I (low risk) device regulated under 21 CFR 862.1390.