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FDA 510(k)

BIO-RAD URINARY 5-HIAA BY HPLC

K-Number: K952817 · 1995-08-01

ApplicantBio-Rad
Decision Date1995-08-01
Product CodeCDA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD URINARY 5-HIAA BY HPLC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1995-08-01 under 510(k) number K952817. The device is classified under product code CDA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-RAD URINARY 5-HIAA BY HPLC?

BIO-RAD URINARY 5-HIAA BY HPLC is a medical device that received FDA 510(k) clearance on 1995-08-01. The listed applicant is Bio-Rad. The 510(k) number is K952817.

When did BIO-RAD URINARY 5-HIAA BY HPLC receive FDA 510(k) clearance?

BIO-RAD URINARY 5-HIAA BY HPLC received FDA 510(k) clearance on 1995-08-01, under 510(k) number K952817.

Who is the listed applicant for BIO-RAD URINARY 5-HIAA BY HPLC?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-RAD URINARY 5-HIAA BY HPLC?

The FDA product code for BIO-RAD URINARY 5-HIAA BY HPLC is CDA.

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Related Devices (Code: CDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K903609SEROTONIN ENZYME IMMUNOASSAYImmunotech Corp.K854946TDXR 5-HIAA (URINE)Abbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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