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FDA 510(k)

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

K-Number: K873064 · 1987-11-04

ApplicantAmtec Diagnostics International, Inc.
Decision Date1987-11-04
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amtec Diagnostics International, Inc.. It received FDA 510(k) clearance on 1987-11-04 under 510(k) number K873064. 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 AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT?

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT is a medical device that received FDA 510(k) clearance on 1987-11-04. The listed applicant is Amtec Diagnostics International, Inc.. The 510(k) number is K873064.

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

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT received FDA 510(k) clearance on 1987-11-04, under 510(k) number K873064.

Who is the listed applicant for AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT?

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

What is the FDA product code for AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT?

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

Related Clinical Trials

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Other records listing Amtec Diagnostics International, 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.

K882998ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST

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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