FDA 510(k)

SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN

K-Number: K882909 · 1988-08-29

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1988-08-29

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN 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 1988-08-29 under 510(k) number K882909. 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 - NEW ANTIMICROBIAL AGENT: RIFAMPIN?

SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K882909.

When did SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN receive FDA 510(k) clearance?

SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN received FDA 510(k) clearance on 1988-08-29, under 510(k) number K882909.

Who is the listed applicant for SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN?

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 - NEW ANTIMICROBIAL AGENT: RIFAMPIN?

The FDA product code for SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN 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.