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FDA 510(k)

SOPHEIA MP IGM RHEUMATOID FACTOR EIA

K-Number: K840049 · 1984-02-10

ApplicantDiagnostic Products Corp.
Decision Date1984-02-10
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SOPHEIA MP IGM RHEUMATOID FACTOR EIA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K840049. 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 SOPHEIA MP IGM RHEUMATOID FACTOR EIA?

SOPHEIA MP IGM RHEUMATOID FACTOR EIA is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K840049.

When did SOPHEIA MP IGM RHEUMATOID FACTOR EIA receive FDA 510(k) clearance?

SOPHEIA MP IGM RHEUMATOID FACTOR EIA received FDA 510(k) clearance on 1984-02-10, under 510(k) number K840049.

Who is the listed applicant for SOPHEIA MP IGM RHEUMATOID FACTOR EIA?

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

What is the FDA product code for SOPHEIA MP IGM RHEUMATOID FACTOR EIA?

The FDA product code for SOPHEIA MP IGM RHEUMATOID FACTOR EIA is DHR.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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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