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FDA 510(k)

SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K-Number: K964501 · 1997-02-06

ApplicantUnipath , Ltd.
Decision Date1997-02-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964501. 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 SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Unipath , Ltd.. The 510(k) number is K964501.

When did SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC receive FDA 510(k) clearance?

SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964501.

Who is the listed applicant for SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

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

What is the FDA product code for SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

The FDA product code for SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC 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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