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Bactec Nap Tb Differentiation Test

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K822946

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822946 Date12 Nov 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JTO
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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