FDA 510(k)

SCEPTOR STREPTOCOCCUS MIC PANEL #80322

K-Number: K883549 · 1988-09-26

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1988-09-26

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SCEPTOR STREPTOCOCCUS MIC PANEL #80322 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 K883549. 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 STREPTOCOCCUS MIC PANEL #80322?

SCEPTOR STREPTOCOCCUS MIC PANEL #80322 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 K883549.

When did SCEPTOR STREPTOCOCCUS MIC PANEL #80322 receive FDA 510(k) clearance?

SCEPTOR STREPTOCOCCUS MIC PANEL #80322 received FDA 510(k) clearance on 1988-09-26, under 510(k) number K883549.

Who is the listed applicant for SCEPTOR STREPTOCOCCUS MIC PANEL #80322?

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 STREPTOCOCCUS MIC PANEL #80322?

The FDA product code for SCEPTOR STREPTOCOCCUS MIC PANEL #80322 is JWY.

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Official Source

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