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FDA 510(k)

NABI RF-Q.S. TEST

K-Number: K840005 · 1984-02-13

ApplicantIntl. Diagnostic, Inc.
Decision Date1984-02-13
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NABI RF-Q.S. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic, Inc.. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K840005. 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 NABI RF-Q.S. TEST?

NABI RF-Q.S. TEST is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K840005.

When did NABI RF-Q.S. TEST receive FDA 510(k) clearance?

NABI RF-Q.S. TEST received FDA 510(k) clearance on 1984-02-13, under 510(k) number K840005.

Who is the listed applicant for NABI RF-Q.S. TEST?

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

What is the FDA product code for NABI RF-Q.S. TEST?

The FDA product code for NABI RF-Q.S. TEST is DHR.

Other records listing Intl. Diagnostic, 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.

K841853PREG-BETA ONE HOUR TUBE TESTK840833PREG BETA BLUS SLIDEK834584NABI CRP-Q.S. TESTK802343PREGNA B-ANTI HUMAN CHORIONIC GONADOTROK780321PREGNANCY TEST KIT, OVER-THE-COUNTER

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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