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FDA 510(k)

CITREX III

K-Number: K853078 · 1985-08-12

Decision Date1985-08-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CITREX III is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K853078. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CITREX III?

CITREX III is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Bio/Data Corp.. The 510(k) number is K853078.

When did CITREX III receive FDA 510(k) clearance?

CITREX III received FDA 510(k) clearance on 1985-08-12, under 510(k) number K853078.

Who is the listed applicant for CITREX III?

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

What is the FDA product code for CITREX III?

The FDA product code for CITREX III is JPA.

Related Clinical Trials

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.

Other records listing Bio/Data Corp. as applicant

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.

View all 37 devices →

Related Devices (Code: JPA)

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.

Official Source

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

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