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FDA 510(k)

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK

K-Number: K955669 · 1996-02-23

ApplicantRemel Co.
Decision Date1996-02-23
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1996-02-23 under 510(k) number K955669. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK?

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK is a medical device that received FDA 510(k) clearance on 1996-02-23. The listed applicant is Remel Co.. The 510(k) number is K955669.

When did REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK receive FDA 510(k) clearance?

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK received FDA 510(k) clearance on 1996-02-23, under 510(k) number K955669.

Who is the listed applicant for REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK?

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 REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK?

The FDA product code for REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK is JTN.

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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. IIIK965152A.C.T. IIK965150A.C.T. IVK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JTN)

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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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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