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FDA 510(k)

MEGACOLOR

K-Number: K860319 · 1986-02-20

ApplicantCytocolor, Inc.
Decision Date1986-02-20
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEGACOLOR is the device name listed in this FDA 510(k) record. The listed applicant is Cytocolor, Inc.. It received FDA 510(k) clearance on 1986-02-20 under 510(k) number K860319. The device is classified under product code LED. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGACOLOR?

MEGACOLOR is a medical device that received FDA 510(k) clearance on 1986-02-20. The listed applicant is Cytocolor, Inc.. The 510(k) number is K860319.

When did MEGACOLOR receive FDA 510(k) clearance?

MEGACOLOR received FDA 510(k) clearance on 1986-02-20, under 510(k) number K860319.

Who is the listed applicant for MEGACOLOR?

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

What is the FDA product code for MEGACOLOR?

The FDA product code for MEGACOLOR is LED.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cytocolor, 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.

K860321LYSOCOLORK860316PANOPTIKONK860320GRANULOCOLORK860317NEUTROCOLOR

Related Devices (Code: LED)

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.

K051409SLIVASUREScandinavian Formulas, Inc.K023046SST SALIVA SUPPORTING TABLETSSinclair Pharmaceuticals, Ltd.K860795SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.K860320GRANULOCOLORCytocolor, Inc.K860316PANOPTIKONCytocolor, Inc.K860321LYSOCOLORCytocolor, 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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