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FDA 510(k)

RUBALEX (REVISED VERSION)

K-Number: K861881 · 1986-06-04

ApplicantOrion Corp.
Decision Date1986-06-04
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBALEX (REVISED VERSION) is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-06-04 under 510(k) number K861881. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBALEX (REVISED VERSION)?

RUBALEX (REVISED VERSION) is a medical device that received FDA 510(k) clearance on 1986-06-04. The listed applicant is Orion Corp.. The 510(k) number is K861881.

When did RUBALEX (REVISED VERSION) receive FDA 510(k) clearance?

RUBALEX (REVISED VERSION) received FDA 510(k) clearance on 1986-06-04, under 510(k) number K861881.

Who is the listed applicant for RUBALEX (REVISED VERSION)?

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

What is the FDA product code for RUBALEX (REVISED VERSION)?

The FDA product code for RUBALEX (REVISED VERSION) is LQN.

Related Clinical Trials

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.

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Other records listing Orion Corp. 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

View all 21 devices →

Related Devices (Code: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.

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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