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FDA 510(k)

BETA QUIK STAT

K-Number: K852327 · 1985-08-20

ApplicantPacific Biotech, Inc.
Decision Date1985-08-20
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA QUIK STAT 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 1985-08-20 under 510(k) number K852327. 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 STAT?

BETA QUIK STAT is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K852327.

When did BETA QUIK STAT receive FDA 510(k) clearance?

BETA QUIK STAT received FDA 510(k) clearance on 1985-08-20, under 510(k) number K852327.

Who is the listed applicant for BETA QUIK STAT?

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 STAT?

The FDA product code for BETA QUIK STAT is JHI.

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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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