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Autozyme

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K760123

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760123 Date20 Jul 1976ClearedStatusActive

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  • Withdrawn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 12 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KSK
Device Class
Class II
Regulation
21 CFR Part 864.9400
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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