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Rianen Anit-Double Stranded Deoxyribon

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K843347

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843347 Date5 Oct 1984ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1140-03 FDA Unclassified (pre-2012) initiated 21 Jul 2003

    Product's outer carton label was labeled with an extended expiration date

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DHN
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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