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FDA 510(k)

SPECTINOMYCIN 100 MCG SENSI-DISC

K-Number: K891772 · 1989-08-21

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1989-08-21
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPECTINOMYCIN 100 MCG SENSI-DISC 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 1989-08-21 under 510(k) number K891772. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTINOMYCIN 100 MCG SENSI-DISC?

SPECTINOMYCIN 100 MCG SENSI-DISC is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K891772.

When did SPECTINOMYCIN 100 MCG SENSI-DISC receive FDA 510(k) clearance?

SPECTINOMYCIN 100 MCG SENSI-DISC received FDA 510(k) clearance on 1989-08-21, under 510(k) number K891772.

Who is the listed applicant for SPECTINOMYCIN 100 MCG SENSI-DISC?

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 SPECTINOMYCIN 100 MCG SENSI-DISC?

The FDA product code for SPECTINOMYCIN 100 MCG SENSI-DISC is JTN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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