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Lipase Color [Toyo] Serum Lipase Test Kit

by Toyo Jozo Co., Ltd.

510(k) K897150

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK897150 Date26 Feb 1990ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2149-2008 FDA Unclassified (pre-2012) initiated 14 Apr 2008
    • Terminated Z-2150-2008 FDA Unclassified (pre-2012) initiated 14 Apr 2008
    • Terminated Z-2148-2008 FDA Unclassified (pre-2012) initiated 14 Apr 2008
    • Terminated Z-2151-2008 FDA Unclassified (pre-2012) initiated 14 Apr 2008

    Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.

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  • Withdrawn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
CHI
Device Class
Class I
Regulation
21 CFR Part 862.1465
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent