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FDA 510(k)

RICKETTSIAL IGG AND IGM IFA KIT

K-Number: K864110 · 1987-03-12

ApplicantHillcrest Biologicals
Decision Date1987-03-12
Product CodeGPN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RICKETTSIAL IGG AND IGM IFA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K864110. The device is classified under product code GPN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RICKETTSIAL IGG AND IGM IFA KIT?

RICKETTSIAL IGG AND IGM IFA KIT is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Hillcrest Biologicals. The 510(k) number is K864110.

When did RICKETTSIAL IGG AND IGM IFA KIT receive FDA 510(k) clearance?

RICKETTSIAL IGG AND IGM IFA KIT received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864110.

Who is the listed applicant for RICKETTSIAL IGG AND IGM IFA KIT?

The FDA 510(k) record lists Hillcrest Biologicals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RICKETTSIAL IGG AND IGM IFA KIT?

The FDA product code for RICKETTSIAL IGG AND IGM IFA KIT is GPN.

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Other records listing Hillcrest Biologicals as applicant

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.

K913618ARBOVIRUS IGM IFA TESTK913617ARBOVIRUS IGG IFA TESTK922374Q FEVER IGM IFA TESTK913906Q FEVER IGG IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

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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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