FDA 510(k)

MYCOPLASMA PNEUMONIAE

K-Number: K843664 · 1984-10-25

Decision Date1984-10-25

Product CodeGSB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE is the device name listed in this FDA 510(k) record. The listed applicant is Institute Virion , Ltd.. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K843664. 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?

MYCOPLASMA PNEUMONIAE is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Institute Virion , Ltd.. The 510(k) number is K843664.

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

MYCOPLASMA PNEUMONIAE received FDA 510(k) clearance on 1984-10-25, under 510(k) number K843664.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE?

The FDA 510(k) record lists Institute Virion , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYCOPLASMA PNEUMONIAE?

The FDA product code for MYCOPLASMA PNEUMONIAE is GSB.

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Other records listing Institute Virion , Ltd. as applicant

K862814COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI K843660IN FLUENZA B VIRUS K843657CYTOMEGALOVIRUS K843658H. SIMPLEX VIRUS K843662MEASLES VIRUS RUBEOLA K843673RESPIRATORY SYNCYTIAL VIRUS

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Related Devices (Code: GSB)

K852933MYCOPLASMA SPP SEROLOGICAL REAGENTSMicrobix Biosystems, Inc.K834338MYCOPLASMA PNEUMONIAE CF ANTIGENHillcrest Biologicals 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.