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FDA 510(k)

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

K-Number: K810221 · 1981-02-09

ApplicantScripps-Miles, Inc.
Decision Date1981-02-09
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL is the device name listed in this FDA 510(k) record. The listed applicant is Scripps-Miles, Inc.. It received FDA 510(k) clearance on 1981-02-09 under 510(k) number K810221. 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 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL?

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL is a medical device that received FDA 510(k) clearance on 1981-02-09. The listed applicant is Scripps-Miles, Inc.. The 510(k) number is K810221.

When did SCRIPPSERA THEUMATOID FACTOR REFER. CNTL receive FDA 510(k) clearance?

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL received FDA 510(k) clearance on 1981-02-09, under 510(k) number K810221.

Who is the listed applicant for SCRIPPSERA THEUMATOID FACTOR REFER. CNTL?

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

What is the FDA product code for SCRIPPSERA THEUMATOID FACTOR REFER. CNTL?

The FDA product code for SCRIPPSERA THEUMATOID FACTOR REFER. CNTL is DHR.

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Other records listing Scripps-Miles, Inc. as applicant

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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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