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FDA 510(k)

PBI BHCG RIA KIT

K-Number: K831302 · 1983-06-08

ApplicantPacific Biotech, Inc.
Decision Date1983-06-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PBI BHCG 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 1983-06-08 under 510(k) number K831302. 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 PBI BHCG RIA KIT?

PBI BHCG RIA KIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K831302.

When did PBI BHCG RIA KIT receive FDA 510(k) clearance?

PBI BHCG RIA KIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831302.

Who is the listed applicant for PBI BHCG 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 PBI BHCG RIA KIT?

The FDA product code for PBI BHCG RIA KIT is JHI.

Other records listing Pacific Biotech, Inc. as applicant

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Related Devices (Code: JHI)

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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