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FDA 510(k)

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR

K-Number: K863238 · 1986-10-08

ApplicantBiostar Medical Products, Inc.
Decision Date1986-10-08
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biostar Medical Products, Inc.. It received FDA 510(k) clearance on 1986-10-08 under 510(k) number K863238. 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 READS RF TEST KIT FOR IGM RHEUMATOID FACTOR?

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR is a medical device that received FDA 510(k) clearance on 1986-10-08. The listed applicant is Biostar Medical Products, Inc.. The 510(k) number is K863238.

When did READS RF TEST KIT FOR IGM RHEUMATOID FACTOR receive FDA 510(k) clearance?

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR received FDA 510(k) clearance on 1986-10-08, under 510(k) number K863238.

Who is the listed applicant for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR?

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

What is the FDA product code for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR?

The FDA product code for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR is DHR.

Related Clinical Trials

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.

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Other records listing Biostar Medical Products, 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.

K893896QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNAK893897SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGMK861499BIOSTAR* READS* IMMUNE COMPLEX ASSAY KITK853697BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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