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FDA 510(k)

BACTICARD STREP

K-Number: K936021 · 1994-05-20

ApplicantRemel Co.
Decision Date1994-05-20
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTICARD STREP is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1994-05-20 under 510(k) number K936021. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTICARD STREP?

BACTICARD STREP is a medical device that received FDA 510(k) clearance on 1994-05-20. The listed applicant is Remel Co.. The 510(k) number is K936021.

When did BACTICARD STREP receive FDA 510(k) clearance?

BACTICARD STREP received FDA 510(k) clearance on 1994-05-20, under 510(k) number K936021.

Who is the listed applicant for BACTICARD STREP?

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 BACTICARD STREP?

The FDA product code for BACTICARD STREP is JTO.

Related Clinical Trials

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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: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic 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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