FDA 510(k)

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE

K-Number: K891577 · 1989-06-02

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1989-06-02

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE 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 1989-06-02 under 510(k) number K891577. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCEPTOR DATA MANAGEMENT CENTER SOFTWARE?

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE is a medical device that received FDA 510(k) clearance on 1989-06-02. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K891577.

When did SCEPTOR DATA MANAGEMENT CENTER SOFTWARE receive FDA 510(k) clearance?

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE received FDA 510(k) clearance on 1989-06-02, under 510(k) number K891577.

Who is the listed applicant for SCEPTOR DATA MANAGEMENT CENTER SOFTWARE?

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 DATA MANAGEMENT CENTER SOFTWARE?

The FDA product code for SCEPTOR DATA MANAGEMENT CENTER SOFTWARE is LON.

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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.