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FDA 510(k)

MYCOPLASMA PNEUMONIAE CF ANTIGEN

K-Number: K834338 · 1984-02-27

ApplicantHillcrest Biologicals
Decision Date1984-02-27
Product CodeGSB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE CF ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K834338. The device is classified under product code GSB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOPLASMA PNEUMONIAE CF ANTIGEN?

MYCOPLASMA PNEUMONIAE CF ANTIGEN is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Hillcrest Biologicals. The 510(k) number is K834338.

When did MYCOPLASMA PNEUMONIAE CF ANTIGEN receive FDA 510(k) clearance?

MYCOPLASMA PNEUMONIAE CF ANTIGEN received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834338.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE CF ANTIGEN?

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 MYCOPLASMA PNEUMONIAE CF ANTIGEN?

The FDA product code for MYCOPLASMA PNEUMONIAE CF ANTIGEN is GSB.

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

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Related Devices (Code: GSB)

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.

K852933MYCOPLASMA SPP SEROLOGICAL REAGENTSMicrobix Biosystems, Inc.K843664MYCOPLASMA PNEUMONIAEInstitute Virion , Ltd.K832132SERA-TEK MYCOPLASMA ANTIBODY TESTMiles Laboratories, Inc.K802934MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROLOrion Diagnostica, Inc.

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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