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FDA 510(k)

REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK

K-Number: K933118 · 1993-08-10

ApplicantRemel Co.
Decision Date1993-08-10
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL CLARITHROMYCIN 15 MCG 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 1993-08-10 under 510(k) number K933118. 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 CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK?

REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Remel Co.. The 510(k) number is K933118.

When did REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK receive FDA 510(k) clearance?

REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK received FDA 510(k) clearance on 1993-08-10, under 510(k) number K933118.

Who is the listed applicant for REMEL CLARITHROMYCIN 15 MCG 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 CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK?

The FDA product code for REMEL CLARITHROMYCIN 15 MCG 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.

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Related Devices (Code: JTN)

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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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