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FDA 510(k)

MYCOPLASMA SPP SEROLOGICAL REAGENTS

K-Number: K852933 · 1985-08-01

ApplicantMicrobix Biosystems, Inc.
Decision Date1985-08-01
Product CodeGSB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA SPP SEROLOGICAL REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Microbix Biosystems, Inc.. It received FDA 510(k) clearance on 1985-08-01 under 510(k) number K852933. 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 SPP SEROLOGICAL REAGENTS?

MYCOPLASMA SPP SEROLOGICAL REAGENTS is a medical device that received FDA 510(k) clearance on 1985-08-01. The listed applicant is Microbix Biosystems, Inc.. The 510(k) number is K852933.

When did MYCOPLASMA SPP SEROLOGICAL REAGENTS receive FDA 510(k) clearance?

MYCOPLASMA SPP SEROLOGICAL REAGENTS received FDA 510(k) clearance on 1985-08-01, under 510(k) number K852933.

Who is the listed applicant for MYCOPLASMA SPP SEROLOGICAL REAGENTS?

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

What is the FDA product code for MYCOPLASMA SPP SEROLOGICAL REAGENTS?

The FDA product code for MYCOPLASMA SPP SEROLOGICAL REAGENTS is GSB.

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Other records listing Microbix Biosystems, Inc. as applicant

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K894262RUBELLA ANTIGEN AND CONTROL ANTIGENK894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROK852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTRK852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTK852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

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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.

K843664MYCOPLASMA PNEUMONIAEInstitute Virion , Ltd.K834338MYCOPLASMA PNEUMONIAE CF ANTIGENHillcrest BiologicalsK832132SERA-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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