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FDA 510(k)

MYOLEX

K-Number: K863730 · 1986-10-15

ApplicantOrion Corp.
Decision Date1986-10-15
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MYOLEX is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-10-15 under 510(k) number K863730. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOLEX?

MYOLEX is a medical device that received FDA 510(k) clearance on 1986-10-15. The listed applicant is Orion Corp.. The 510(k) number is K863730.

When did MYOLEX receive FDA 510(k) clearance?

MYOLEX received FDA 510(k) clearance on 1986-10-15, under 510(k) number K863730.

Who is the listed applicant for MYOLEX?

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 MYOLEX?

The FDA product code for MYOLEX is DDR.

Related Clinical Trials

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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

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Related Devices (Code: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics 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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