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FDA 510(k)

BETA-QUIK-15 RIA KIT

K-Number: K831223 · 1983-06-02

ApplicantPacific Biotech, Inc.
Decision Date1983-06-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA-QUIK-15 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 1983-06-02 under 510(k) number K831223. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA-QUIK-15 RIA KIT?

BETA-QUIK-15 RIA KIT is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K831223.

When did BETA-QUIK-15 RIA KIT receive FDA 510(k) clearance?

BETA-QUIK-15 RIA KIT received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831223.

Who is the listed applicant for BETA-QUIK-15 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 BETA-QUIK-15 RIA KIT?

The FDA product code for BETA-QUIK-15 RIA KIT is JHI.

Other records listing Pacific Biotech, Inc. as applicant

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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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