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FDA 510(k)

QUANTA LITE RF IGG ELISA

K-Number: K983083 · 1998-11-04

ApplicantInova Diagnostics, Inc.
Decision Date1998-11-04
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE RF IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K983083. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE RF IGG ELISA?

QUANTA LITE RF IGG ELISA is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K983083.

When did QUANTA LITE RF IGG ELISA receive FDA 510(k) clearance?

QUANTA LITE RF IGG ELISA received FDA 510(k) clearance on 1998-11-04, under 510(k) number K983083.

Who is the listed applicant for QUANTA LITE RF IGG ELISA?

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

What is the FDA product code for QUANTA LITE RF IGG ELISA?

The FDA product code for QUANTA LITE RF IGG ELISA is DHR.

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Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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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