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FDA 510(k)

INSTANT EOSIN-ALCOHOLIC

K-Number: K880240 · 1988-03-03

ApplicantShandon, Inc.
Decision Date1988-03-03
Product CodeHYB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INSTANT EOSIN-ALCOHOLIC is the device name listed in this FDA 510(k) record. The listed applicant is Shandon, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880240. The device is classified under product code HYB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTANT EOSIN-ALCOHOLIC?

INSTANT EOSIN-ALCOHOLIC is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Shandon, Inc.. The 510(k) number is K880240.

When did INSTANT EOSIN-ALCOHOLIC receive FDA 510(k) clearance?

INSTANT EOSIN-ALCOHOLIC received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880240.

Who is the listed applicant for INSTANT EOSIN-ALCOHOLIC?

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

What is the FDA product code for INSTANT EOSIN-ALCOHOLIC?

The FDA product code for INSTANT EOSIN-ALCOHOLIC is HYB.

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 Shandon, 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.

K893663INSTANT EOSIN-AQUEOUSK890984LINISTAIN SLSK873107INSTANT HEMATOXYLINK780261COVERSLIPPER

Related Devices (Code: HYB)

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.

K893663INSTANT EOSIN-AQUEOUSShandon, Inc.K880596EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINESigma Chemical Co.K843426EOSIN Y 1% ALCOHOLICAccra Laboratories, Inc.K822982MIDAS 100 HEMACOLOR STAIN #66030Emd Chemicals, Inc.K821574EOSIN Y SOLUTIN, AGUEOUSSigma Chemical Co.K821573EOSIN Y SOLUTION ALCHOLICSigma Chemical Co.

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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