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FDA 510(k)

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL

K-Number: K802934 · 1980-12-31

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-31
Product CodeGSB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K802934. 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 ANTIGEN & CONTROL?

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802934.

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

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL received FDA 510(k) clearance on 1980-12-31, under 510(k) number K802934.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL?

The FDA 510(k) record lists Orion Diagnostica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL?

The FDA product code for MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL is GSB.

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Other records listing Orion Diagnostica, Inc. as applicant

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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.K834338MYCOPLASMA PNEUMONIAE CF ANTIGENHillcrest BiologicalsK832132SERA-TEK MYCOPLASMA ANTIBODY TESTMiles Laboratories, 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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