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FDA 510(k)

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM

K-Number: K950073 · 1995-10-17

ApplicantShared Systems, Inc.
Decision Date1995-10-17
Product CodeGSA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shared Systems, Inc.. It received FDA 510(k) clearance on 1995-10-17 under 510(k) number K950073. 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 AGGLUTINATION TEST SYSTEM?

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-17. The listed applicant is Shared Systems, Inc.. The 510(k) number is K950073.

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

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM received FDA 510(k) clearance on 1995-10-17, under 510(k) number K950073.

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

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

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Shared Systems, 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.

K973457CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800K955042CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEMK953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEMK920212MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

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.

K910833COLOR VUE TM- MYCOPLASMA PNEUMONIAESeradyn, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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