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FDA 510(k)

UBI MAGIWEL RF-IGM QUANTITATIVE

K-Number: K883355 · 1988-09-07

ApplicantUnited Biotech, Inc.
Decision Date1988-09-07
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL RF-IGM QUANTITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K883355. 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 UBI MAGIWEL RF-IGM QUANTITATIVE?

UBI MAGIWEL RF-IGM QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is United Biotech, Inc.. The 510(k) number is K883355.

When did UBI MAGIWEL RF-IGM QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL RF-IGM QUANTITATIVE received FDA 510(k) clearance on 1988-09-07, under 510(k) number K883355.

Who is the listed applicant for UBI MAGIWEL RF-IGM QUANTITATIVE?

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

What is the FDA product code for UBI MAGIWEL RF-IGM QUANTITATIVE?

The FDA product code for UBI MAGIWEL RF-IGM QUANTITATIVE is DHR.

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Other records listing United Biotech, 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.

K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEK973155UBI MAGIWEL OPIATE METABOLITESK973156UBI MAGIWEL COCAINE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITES

View all 22 devices →

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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