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FDA 510(k)

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN

K-Number: K983301 · 1998-11-25

ApplicantAccumed Intl., Inc.
Decision Date1998-11-25
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN 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 1998-11-25 under 510(k) number K983301. The device is classified under product code JWY. 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 TROVAFLOXACIN?

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K983301.

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

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983301.

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

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 TROVAFLOXACIN?

The FDA product code for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN is JWY.

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Other records listing Accumed Intl., Inc. 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.

K984489SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESK983306SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACINK983310SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACINK983309SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACINK982786TRACCELL 2000 SLIDE MAPPING SYSTEMK972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90

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Related Devices (Code: JWY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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