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FDA 510(k)

RAPET RF

K-Number: K974370 · 1998-02-17

ApplicantStanbio Laboratory
Decision Date1998-02-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAPET RF is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K974370. 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 RAPET RF?

RAPET RF is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Stanbio Laboratory. The 510(k) number is K974370.

When did RAPET RF receive FDA 510(k) clearance?

RAPET RF received FDA 510(k) clearance on 1998-02-17, under 510(k) number K974370.

Who is the listed applicant for RAPET RF?

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

What is the FDA product code for RAPET RF?

The FDA product code for RAPET RF is DHR.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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