FDA 510(k)

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN

K-Number: K983306 · 1998-12-18

Decision Date1998-12-18

Product CodeLTT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1998-12-18 under 510(k) number K983306. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN?

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN is a medical device that received FDA 510(k) clearance on 1998-12-18. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K983306.

When did SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN receive FDA 510(k) clearance?

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN received FDA 510(k) clearance on 1998-12-18, under 510(k) number K983306.

Who is the listed applicant for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN?

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

What is the FDA product code for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN?

The FDA product code for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN is LTT.

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Other records listing Accumed Intl., Inc. as applicant

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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.