FDA 510(k)

SCEPTOR STAPHYLOCOCCUS MIC #80324

K-Number: K883550 · 1988-09-26

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1988-09-26

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SCEPTOR STAPHYLOCOCCUS MIC #80324 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1988-09-26 under 510(k) number K883550. 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 SCEPTOR STAPHYLOCOCCUS MIC #80324?

SCEPTOR STAPHYLOCOCCUS MIC #80324 is a medical device that received FDA 510(k) clearance on 1988-09-26. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K883550.

When did SCEPTOR STAPHYLOCOCCUS MIC #80324 receive FDA 510(k) clearance?

SCEPTOR STAPHYLOCOCCUS MIC #80324 received FDA 510(k) clearance on 1988-09-26, under 510(k) number K883550.

Who is the listed applicant for SCEPTOR STAPHYLOCOCCUS MIC #80324?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCEPTOR STAPHYLOCOCCUS MIC #80324?

The FDA product code for SCEPTOR STAPHYLOCOCCUS MIC #80324 is 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.