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FDA 510(k)

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM

K-Number: K862630 · 1986-09-03

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1986-09-03
Product CodeGSA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1986-09-03 under 510(k) number K862630. 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 MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM?

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-09-03. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K862630.

When did MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM receive FDA 510(k) clearance?

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM received FDA 510(k) clearance on 1986-09-03, under 510(k) number K862630.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM?

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

What is the FDA product code for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM?

The FDA product code for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM is GSA.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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.K910833COLOR VUE TM- MYCOPLASMA PNEUMONIAESeradyn, Inc.K905493MERISTAR-MPMeridian Diagnostics, Inc.K903958SEROFASTIntl. Mycoplasma/Mdc Assoc.K883083MYCOPLASMA 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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