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FDA 510(k)

VISTA IMMUNOASSAY SYSTEM -- MODIFICATION

K-Number: K922139 · 1992-07-21

ApplicantSyva Co.
Decision Date1992-07-21
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISTA IMMUNOASSAY SYSTEM -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1992-07-21 under 510(k) number K922139. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA IMMUNOASSAY SYSTEM -- MODIFICATION?

VISTA IMMUNOASSAY SYSTEM -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-07-21. The listed applicant is Syva Co.. The 510(k) number is K922139.

When did VISTA IMMUNOASSAY SYSTEM -- MODIFICATION receive FDA 510(k) clearance?

VISTA IMMUNOASSAY SYSTEM -- MODIFICATION received FDA 510(k) clearance on 1992-07-21, under 510(k) number K922139.

Who is the listed applicant for VISTA IMMUNOASSAY SYSTEM -- MODIFICATION?

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

What is the FDA product code for VISTA IMMUNOASSAY SYSTEM -- MODIFICATION?

The FDA product code for VISTA IMMUNOASSAY SYSTEM -- MODIFICATION is JJE.

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Other records listing Syva Co. 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.

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Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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