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FDA 510(k)

COLOR VUE TM- MYCOPLASMA PNEUMONIAE

K-Number: K910833 · 1991-06-24

ApplicantSeradyn, Inc.
Decision Date1991-06-24
Product CodeGSA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLOR VUE TM- MYCOPLASMA PNEUMONIAE is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K910833. The device is classified under product code GSA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOR VUE TM- MYCOPLASMA PNEUMONIAE?

COLOR VUE TM- MYCOPLASMA PNEUMONIAE is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Seradyn, Inc.. The 510(k) number is K910833.

When did COLOR VUE TM- MYCOPLASMA PNEUMONIAE receive FDA 510(k) clearance?

COLOR VUE TM- MYCOPLASMA PNEUMONIAE received FDA 510(k) clearance on 1991-06-24, under 510(k) number K910833.

Who is the listed applicant for COLOR VUE TM- MYCOPLASMA PNEUMONIAE?

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

What is the FDA product code for COLOR VUE TM- MYCOPLASMA PNEUMONIAE?

The FDA product code for COLOR VUE TM- MYCOPLASMA PNEUMONIAE is GSA.

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Other records listing Seradyn, Inc. 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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Related Devices (Code: GSA)

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.

K950073MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMShared Systems, Inc.K905493MERISTAR-MPMeridian Diagnostics, Inc.K903958SEROFASTIntl. Mycoplasma/Mdc Assoc.K883083MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEMMedical Diagnostic Technologies, Inc.K862630MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEMMedical Diagnostic Technologies, 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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