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FDA 510(k)

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST

K-Number: K962015 · 1996-11-25

ApplicantTeco Diagnostics
Decision Date1996-11-25
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K962015. 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 RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST?

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Teco Diagnostics. The 510(k) number is K962015.

When did RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST receive FDA 510(k) clearance?

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST received FDA 510(k) clearance on 1996-11-25, under 510(k) number K962015.

Who is the listed applicant for RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST?

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

What is the FDA product code for RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST?

The FDA product code for RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST is DHR.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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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