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FDA 510(k)

POLYCHROME IV STAIN

K-Number: K854176 · 1985-10-31

ApplicantDevetec, Inc.
Decision Date1985-10-31
Product CodeLED
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLYCHROME IV STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Devetec, Inc.. It received FDA 510(k) clearance on 1985-10-31 under 510(k) number K854176. 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 POLYCHROME IV STAIN?

POLYCHROME IV STAIN is a medical device that received FDA 510(k) clearance on 1985-10-31. The listed applicant is Devetec, Inc.. The 510(k) number is K854176.

When did POLYCHROME IV STAIN receive FDA 510(k) clearance?

POLYCHROME IV STAIN received FDA 510(k) clearance on 1985-10-31, under 510(k) number K854176.

Who is the listed applicant for POLYCHROME IV STAIN?

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

What is the FDA product code for POLYCHROME IV STAIN?

The FDA product code for POLYCHROME IV STAIN 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.

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Other records listing Devetec, 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.

K894045MODIFIED POLYCHROME IV STAINK873594TIF FECAL TESTK870988PRICE'S ACID-FAST STAIN

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.K860319MEGACOLORCytocolor, Inc.K860316PANOPTIKONCytocolor, Inc.K860321LYSOCOLORCytocolor, Inc.

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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