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Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol

by Solution Technologies

510(k) K981043

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981043 Date26 May 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1612-2012 FDA Not yet classified initiated 16 Mar 2012

    Sodium content does not meet product requirements

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  • Withdrawn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
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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