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FDA 510(k)

PRL QUIK RIA KIT

K-Number: K850383 · 1985-03-01

ApplicantPacific Biotech, Inc.
Decision Date1985-03-01
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRL QUIK RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850383. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRL QUIK RIA KIT?

PRL QUIK RIA KIT is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K850383.

When did PRL QUIK RIA KIT receive FDA 510(k) clearance?

PRL QUIK RIA KIT received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850383.

Who is the listed applicant for PRL QUIK RIA KIT?

The FDA 510(k) record lists Pacific Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRL QUIK RIA KIT?

The FDA product code for PRL QUIK RIA KIT is CFT.

Other records listing Pacific Biotech, Inc. as applicant

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Related Devices (Code: CFT)

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.

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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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