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1.5 M Propanediol Freezing Medium, 1.5 Propanediol 0.1 Sucrose Freezing Medium, 9% Glycerol, 0.2 M Sucrose Freezing Medi

by Sage Biopharma

510(k) K991390

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991390 Date18 Jan 2000ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2851-2016 FDA Class III initiated 25 Aug 2016
    • Terminated Z-2850-2016 FDA Class III initiated 25 Aug 2016

    Products contain international package insert and not the correct USA package insert

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  • Withdrawn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
MQL
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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