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FDA 510(k)

PLASMA EXTRACTION SYSTEM

K-Number: K850391 · 1985-05-10

ApplicantHans J. Brouwers & Assoc.
Decision Date1985-05-10
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLASMA EXTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hans J. Brouwers & Assoc.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K850391. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA EXTRACTION SYSTEM?

PLASMA EXTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Hans J. Brouwers & Assoc.. The 510(k) number is K850391.

When did PLASMA EXTRACTION SYSTEM receive FDA 510(k) clearance?

PLASMA EXTRACTION SYSTEM received FDA 510(k) clearance on 1985-05-10, under 510(k) number K850391.

Who is the listed applicant for PLASMA EXTRACTION SYSTEM?

The FDA 510(k) record lists Hans J. Brouwers & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLASMA EXTRACTION SYSTEM?

The FDA product code for PLASMA EXTRACTION SYSTEM is JPI.

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Other records listing Hans J. Brouwers & Assoc. 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.

K850390CHOLESTEROL TEST SYSTEM

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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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