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FDA 510(k)

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK

K-Number: K970830 · 1997-04-02

ApplicantRemel, Inc.
Decision Date1997-04-02
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K970830. 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 LEVOFLOXACIN 5G SUSCEPTIBILTY DISK?

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Remel, Inc.. The 510(k) number is K970830.

When did REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK receive FDA 510(k) clearance?

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970830.

Who is the listed applicant for REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK?

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

What is the FDA product code for REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK?

The FDA product code for REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK is 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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