FDA 510(k)

SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL

K-Number: K854099 · 1985-11-14

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1985-11-14

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL 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 1985-11-14 under 510(k) number K854099. 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 GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL?

SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K854099.

When did SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL receive FDA 510(k) clearance?

SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL received FDA 510(k) clearance on 1985-11-14, under 510(k) number K854099.

Who is the listed applicant for SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL?

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 GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL?

The FDA product code for SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL 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.