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FDA 510(k)

CITREX II

K-Number: K853077 · 1985-08-12

ApplicantBio/Data Corp.
Decision Date1985-08-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CITREX II 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 K853077. 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 II?

CITREX II 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 K853077.

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

CITREX II received FDA 510(k) clearance on 1985-08-12, under 510(k) number K853077.

Who is the listed applicant for CITREX II?

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 II?

The FDA product code for CITREX II is JPA.

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Other records listing Bio/Data Corp. as applicant

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Related Devices (Code: JPA)

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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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