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FDA 510(k)

ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT

K-Number: K971602 · 1997-06-27

ApplicantBeckman Instruments, Inc.
Decision Date1997-06-27
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971602. 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 ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT?

ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K971602.

When did ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT receive FDA 510(k) clearance?

ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971602.

Who is the listed applicant for ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT?

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

What is the FDA product code for ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT?

The FDA product code for ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT is DHR.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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