FDA 510(k)

EOSIN Y SOLUTIN, AGUEOUS

K-Number: K821574 · 1982-06-10

Decision Date1982-06-10

Product CodeHYB

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

EOSIN Y SOLUTIN, AGUEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K821574. 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 EOSIN Y SOLUTIN, AGUEOUS?

EOSIN Y SOLUTIN, AGUEOUS is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Sigma Chemical Co.. The 510(k) number is K821574.

When did EOSIN Y SOLUTIN, AGUEOUS receive FDA 510(k) clearance?

EOSIN Y SOLUTIN, AGUEOUS received FDA 510(k) clearance on 1982-06-10, under 510(k) number K821574.

Who is the listed applicant for EOSIN Y SOLUTIN, AGUEOUS?

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

What is the FDA product code for EOSIN Y SOLUTIN, AGUEOUS?

The FDA product code for EOSIN Y SOLUTIN, AGUEOUS is HYB.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: HYB)

K893663INSTANT EOSIN-AQUEOUSShandon, Inc.K880596EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINESigma Chemical Co.K880240INSTANT EOSIN-ALCOHOLICShandon, Inc.K843426EOSIN Y 1% ALCOHOLICAccra Laboratories, Inc.K822982MIDAS 100 HEMACOLOR STAIN #66030Emd Chemicals, Inc.K821573EOSIN Y SOLUTION ALCHOLICSigma Chemical Co.

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.