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FDA 510(k)

TOMTEC GRAM STAINER CRYSTAL VIOLET

K-Number: K871532 · 1987-04-29

ApplicantRemel Co.
Decision Date1987-04-29
Product CodeJTS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TOMTEC GRAM STAINER CRYSTAL VIOLET is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1987-04-29 under 510(k) number K871532. 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 TOMTEC GRAM STAINER CRYSTAL VIOLET?

TOMTEC GRAM STAINER CRYSTAL VIOLET is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Remel Co.. The 510(k) number is K871532.

When did TOMTEC GRAM STAINER CRYSTAL VIOLET receive FDA 510(k) clearance?

TOMTEC GRAM STAINER CRYSTAL VIOLET received FDA 510(k) clearance on 1987-04-29, under 510(k) number K871532.

Who is the listed applicant for TOMTEC GRAM STAINER CRYSTAL VIOLET?

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 TOMTEC GRAM STAINER CRYSTAL VIOLET?

The FDA product code for TOMTEC GRAM STAINER CRYSTAL VIOLET is JTS.

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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.K920975BACTIDROP CALCOFLUOR WHITERemel Co.K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems

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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