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FDA 510(k)

MODIFIED BETA QUIK STAT EIA KIT

K-Number: K882895 · 1988-10-12

ApplicantPacific Biotech, Inc.
Decision Date1988-10-12
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED BETA QUIK STAT EIA 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 1988-10-12 under 510(k) number K882895. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED BETA QUIK STAT EIA KIT?

MODIFIED BETA QUIK STAT EIA KIT is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K882895.

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

MODIFIED BETA QUIK STAT EIA KIT received FDA 510(k) clearance on 1988-10-12, under 510(k) number K882895.

Who is the listed applicant for MODIFIED BETA QUIK STAT EIA 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 MODIFIED BETA QUIK STAT EIA KIT?

The FDA product code for MODIFIED BETA QUIK STAT EIA KIT is DHA.

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Related Devices (Code: DHA)

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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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