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FDA 510(k)

HCG IRMA, CAT. NO. CR-1501

K-Number: K862007 · 1986-07-01

ApplicantPacific Biotech, Inc.
Decision Date1986-07-01
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG IRMA, CAT. NO. CR-1501 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 1986-07-01 under 510(k) number K862007. 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 HCG IRMA, CAT. NO. CR-1501?

HCG IRMA, CAT. NO. CR-1501 is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K862007.

When did HCG IRMA, CAT. NO. CR-1501 receive FDA 510(k) clearance?

HCG IRMA, CAT. NO. CR-1501 received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862007.

Who is the listed applicant for HCG IRMA, CAT. NO. CR-1501?

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 HCG IRMA, CAT. NO. CR-1501?

The FDA product code for HCG IRMA, CAT. NO. CR-1501 is JHI.

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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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