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FDA 510(k)

IMMUNO RA UNDILUTED

K-Number: K926569 · 1993-04-06

ApplicantImmunostics Co., Inc.
Decision Date1993-04-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNO RA UNDILUTED is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1993-04-06 under 510(k) number K926569. 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 IMMUNO RA UNDILUTED?

IMMUNO RA UNDILUTED is a medical device that received FDA 510(k) clearance on 1993-04-06. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K926569.

When did IMMUNO RA UNDILUTED receive FDA 510(k) clearance?

IMMUNO RA UNDILUTED received FDA 510(k) clearance on 1993-04-06, under 510(k) number K926569.

Who is the listed applicant for IMMUNO RA UNDILUTED?

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

What is the FDA product code for IMMUNO RA UNDILUTED?

The FDA product code for IMMUNO RA UNDILUTED is DHR.

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Other records listing Immunostics Co., 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.

K902360HEMA-SCREENK894780IMMUNO/ASOK883685IMMUNO/FEBRILE ANTIGENSK872910IMMUNO/SLEK863741IMMUNO-CEPT D (BETA-MONOCLONAL)K854619DETECTACULT

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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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