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FDA 510(k)

SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT

K-Number: K810141 · 1981-02-09

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

Device Summary

SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT 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 K810141. 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 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT?

SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT 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 K810141.

When did SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT receive FDA 510(k) clearance?

SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT received FDA 510(k) clearance on 1981-02-09, under 510(k) number K810141.

Who is the listed applicant for SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT?

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 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT?

The FDA product code for SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT is DHR.

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Other records listing Scripps-Miles, 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.

K812453SCRIPPSYSTEM IMMUNOGLOBIN RID KITK812328SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KITK811714HEP-2-CRITHIDIA LUCILIAE ANA TEST KITK811433SCRIPPSERA COMPLEMENT CONTROL SERAK810501SCRIPPSYSTEM C3 RID KITK810502SCRIPPSYSTEM C4 RID KIT

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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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