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FDA 510(k)

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)

K-Number: K973464 · 1997-10-22

ApplicantInstrumentation Laboratory CO
Decision Date1997-10-22
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1997-10-22 under 510(k) number K973464. 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 QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)?

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) is a medical device that received FDA 510(k) clearance on 1997-10-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K973464.

When did QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) receive FDA 510(k) clearance?

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) received FDA 510(k) clearance on 1997-10-22, under 510(k) number K973464.

Who is the listed applicant for QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)?

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

What is the FDA product code for QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)?

The FDA product code for QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) 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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