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FDA 510(k)

Q FEVER IGG IFA TEST

K-Number: K913906 · 1992-10-21

ApplicantHillcrest Biologicals
Decision Date1992-10-21
Product CodeGPJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Q FEVER IGG IFA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1992-10-21 under 510(k) number K913906. The device is classified under product code GPJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q FEVER IGG IFA TEST?

Q FEVER IGG IFA TEST is a medical device that received FDA 510(k) clearance on 1992-10-21. The listed applicant is Hillcrest Biologicals. The 510(k) number is K913906.

When did Q FEVER IGG IFA TEST receive FDA 510(k) clearance?

Q FEVER IGG IFA TEST received FDA 510(k) clearance on 1992-10-21, under 510(k) number K913906.

Who is the listed applicant for Q FEVER IGG IFA TEST?

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 Q FEVER IGG IFA TEST?

The FDA product code for Q FEVER IGG IFA TEST is GPJ.

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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.

K913617ARBOVIRUS IGG IFA TESTK913618ARBOVIRUS IGM IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)K884829EBV EARLY ANTIGEN (R+D)

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Related Devices (Code: GPJ)

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.

K922374Q FEVER IGM IFA TESTHillcrest Biologicals

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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