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Prefilled Specimen Container

by Sage Products, Inc.

510(k) K820246

Prefilled Specimen Container is a medical device (FDA Class I; FDA product code KDT, Container, Specimen Mailer And Storage, Sterile) made by Sage Products, Inc., cleared under FDA 510(k) K820246 on 18 Feb 1982, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820246 Date18 Feb 1982ClearedStatusActive

Official records

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  • Withdrawn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
KDT
Device class
Class I
Regulation
21 CFR Part 864.3250
Advisory committee
Pathology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KDT (Container, Specimen Mailer And Storage, Sterile).

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