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FDA 510(k)

BACTIDROP CALCOFLUOR WHITE

K-Number: K920975 · 1992-06-09

ApplicantRemel Co.
Decision Date1992-06-09
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BACTIDROP CALCOFLUOR WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K920975. The device is classified under product code JTS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIDROP CALCOFLUOR WHITE?

BACTIDROP CALCOFLUOR WHITE is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Remel Co.. The 510(k) number is K920975.

When did BACTIDROP CALCOFLUOR WHITE receive FDA 510(k) clearance?

BACTIDROP CALCOFLUOR WHITE received FDA 510(k) clearance on 1992-06-09, under 510(k) number K920975.

Who is the listed applicant for BACTIDROP CALCOFLUOR WHITE?

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

What is the FDA product code for BACTIDROP CALCOFLUOR WHITE?

The FDA product code for BACTIDROP CALCOFLUOR WHITE is JTS.

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 Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JTS)

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.

K960090CALCOFLUOR WHITE STAIN KITRemel Co.K960095BACTIDROP CALCOFLUOR WHITERemel Co.K920970BACTIDROP KOH (10%)Remel Co.K920976BACTIDROP INDIA INKRemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging SystemsK890861ATS DOBELL & O'CONNOR'S IODINEAlpha-Tec Systems, 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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